Maude Abbott: "A Feminine Misfit in an Exclusive Male Environment" and Her Strategies for Success.

Maude Abbott was a pioneering female Canadian physician who became a world authority on medical museums and congenital heart disease. Abbott spent almost all her career in highly sexist, discriminatory work environments. This paper reviews Abbott's life and accomplishments, but, more importantly, analyzes her pathway to success in the masculine world of early 20th-century academic pathology. Abbott, though well-trained as a pathologist, never provided clinical service, but instead worked as museum curator at McGill University. She established the International Association of Medical Museums (predecessor to the International Academy of Pathology), edited its journal, and essentially ran the organization. Abbott, surrounded by influential males, dealt differently with each. In general, she recognized that male doctors believed women lacked the gravitas to lead major initiatives but that she could circumnavigate this supposed impediment by co-leading projects with male counterparts, preferably ones too busy to get in her way. She repeatedly used this approach, and by doing most of the work but sharing credit, succeeded in gaining reputation, accomplishment, and advancement. Abbott's pioneering work on congenital heart disease established her as one of the founders of pediatric pathology, and, overall, her career promoted the entry of women physicians into the pathology profession.

"Under"-reporting of complications following AF ablation: Comparison of the Manufacturer and User Facility Device Experience FDA database and a voluntary invitation-based registry - the POTTER-AF 3 Study.

BACKGROUND: The Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports of adverse events involving medical devices marketed in the United States submitted to the U.S. Food and Drug Administration (FDA) by mandatory and voluntary reporters. The MAUDE database is frequently used in clinical studies to report on device-related complications. Data about its efficacy are scarce. OBJECTIVE: To compare the mandatory MAUDE database (MAUDE group) with the invitation-based POTTER-AF Study (POTTER-AF 1 group) regarding data quality, procedural characteristics, diagnosis, treatment, and survival. METHODS: The reports of esophageal fistula esophageal fistula following atrial fibrillation (AF) ablation in the MAUDE database were compared to those in the POTTER-AF Study between 01/08/2009 and 31/08/2019. RESULTS: Esophageal fistula was reported in 47 patients in the MAUDE group and in 81 in the POTTER-AF 1 group. Procedures were performed with radiofrequency, cryoenergy or laser energy in 66.0%, 31.9% and 2.1% (MAUDE group) and in 96.3%, 2.5% and 1.2% (POTTER-AF 1 group). The median time to symptoms was 21 (14, 32.5) days (MAUDE group) and 18.0 (6.8, 22.3) days (POTTER-AF 1 group; p=0.031). The diagnostic method was reported in 38.3% of patients in the MAUDE group and in 98.8% in the POTTER-AF 1 group, the treatment in 57.4% and 100% and the outcome in all patients. In the MAUDE group, treatment was surgical (51.9%), endoscopic (37.0%), combined (3.7%) or conservative (7.4%), compared to 43.2%, 19.8%, 7.4% and 29.6% in the POTTER-AF 1 group. Overall mortality was 76.6% in the MAUDE group and 61.7% in the POTTER-AF 1 group (p=0.118). CONCLUSION: In the mandatory MAUDE database, less esophageal fistula cases were reported as compared to an invitation-based study. The data quality in the MAUDE database was significantly poorer.

Trends and incidence of reported events associated with ureteral stents: an analysis of the food and drug administration's manufacturer and user facility device experience (MAUDE) database.

PURPOSE: Aim of this study is to summarize medical device reports (MDRs) between 2012 and 2022 relating to ureteral stents within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). METHODS: MAUDE was analyzed for all MDRs relating to each FDA-approved ureteral stent. Event descriptions were reviewed and characterized into specific event types. Outcome measures include specific ureteral stent and reported events as detailed by the MDRs. Data is presented as number of specific event/total events. Pooled Relative risk was used to compare data. RESULTS: 2652 reports were retrieved in 10 years and a progressive rise in reported events was recorded. 831/2652 (31%) were reported as injury while 1810/2652 (68%) as malfunction of the ureteral stent and 4 events of death. The most frequently reported adverse events (AEs) were stent break (627/2652: 23%); material problems (384/2652: 14%); calcification (222/2652: 8%); difficulty to insert, advance or remove the device (155/2652: 6%). Bard stents were associated with most material problems (19%), Resonance stents were associated with most difficulty to insert, advance or remove the device (9%) and calcification (15%) while filiform double pigtail stent set were associated with most breakage reports (56%) when compared to the other stents (PRR > 1, p < 0,05). CONCLUSIONS: According to MAUDE database the most frequent complications related to ureteral stents are breakage, material problems, calcification and difficulty to insert/advance/remove the device. As well Resonance ureteral stents seem to be associated with a higher risk of device problems.

Adverse events related to robotic-assisted knee arthroplasty: a cross-sectional study from the MAUDE database.

BACKGROUND: Robotic-assisted surgical technique has been clinically available for decades, yet real-world adverse events (AEs) and complications associated with primary knee arthroplasty remain unclear. METHODS: In March 2023, we searched the FDA website and extracted AEs related to robotic assisted knee arthroplasty (RAKA) from the MAUDE database over the past 10 years. The "Brand Name" function queried major robotic platforms, including active and semi-active systems. The overall incidence of AEs was estimated based on annual surgical volume from the current American Joint Replacement Registry (AJRR). Two authors independently collected data on event date, event type, device problem, and patient problem. RESULTS: Of 839 eligible reports, device malfunction comprised mechanical failure (343/839, 40.88%) and software failure (261/839, 31.11%). For surgical complications, inappropriate bone resection (115/839, 13.71%) was most frequent, followed by bone/soft tissue damage (83/839, 9.89%). Notably, over-resection exceeding 2 mm (88/839, 10.49%), joint infection (25/839, 2.98%), and aseptic loosening (1/839, 0.12%) were major complications. Only two track pins related AEs were found. Moreover, the distribution of these AEs differed substantially between robot manufacturers. According to the AEs volume and AJRR data, the overall incidences of AEs related to RAKAs were calculated with 0.83% (839/100,892) between November 2010 and March 2023. CONCLUSION: Our analysis shows that while reported AEs might be increasing for RAKAs, the overall rate remains relatively low. Reassuringly, device malfunction was the most commonly AEs observed, with a minor impact on postoperative outcomes. Furthermore, our data provide a benchmark for patients, surgeons, and manufacturers to evaluate RAKA performance, though continued improvement in reducing serious AEs incidence is warranted.

A MAUDE database analysis on the new generation of active bone conduction hearing implants.

Objective: To analyze medical device reports (MDR) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events (AEs) in patients implanted with novel active bone conduction hearing implants (BCIs). Methods: We conducted a search of the FDA MAUDE database on the newest generation of BCIs. Data were collected concerning device malfunctions, patient injuries, factors triggering these incidents, and the subsequent actions taken. Results: In total, 93 (16.7%) device malfunctions and 465 (83.3%) patient injuries with 358 subsequent interventions were identified, resulting in 558 AEs. Although the absolute AE number per device cannot be identified, the following trends were detected: Among the 494 AEs associated with OSI200, 55 (11.1%) reported device malfunctions and 454 (88.9%) cited patient injuries. Out of the 64 AEs linked to BCI602, 28 (59.4%) were associated with malfunctions, whereas 26 (40.6%) involved patient injuries. The most frequently reported particular AEs for the OSI200 were infection (n = 171, 34.6%), extrusion of the device (n = 107, 21.7%), and pain (n = 51, 10.3%). Conversely, no device output (n = 20, 31.3%) and loss of osseointegration (n = 7, 10.9%) were the most reported AEs for the BCI602. Various AEs led to 214 explanations and 77 revision surgeries. Sixty-seven AEs reported conservative treatment. Conclusion: The current study provides an overview of the most commonly reported complications with new active BCIs. Although providing an overview, given the limitations of the FDA MAUDE database, our results have to be interpreted with caution. Level of Evidence: 4.

Analysis of 1027 Adverse Events Reports for Interspinous Process Devices From the US Food and Drug Administration Manufacturer and User Facility Device Experience Database.

BACKGROUND: Interspinous process devices (IPDs) introduce a new class of complications to surgical decompression without fusion: hardware-related complications. The purpose of this study was to describe the adverse events associated with IPDs. STUDY DESIGN: This was a retrospective review of the Food and Drug Administration Manufacturer and User Facility Device Experience database. METHODS: The database was queried from its inception to November 2022 for reports associated with "Prosthesis, Spinous Process Spacer/Plate." Entries were categorized by event type, patient impact, and interventions. RESULTS: A total of 943 surgery-related adverse events were identified. The most common intraoperative events were implant malfunctions (39.7%, n = 374) and fractures (2.2%, n = 21). The most common postoperative events were persistent pain (26.6%, n = 251), implant migration (19.1%, n = 180), and fracture (6.8%, n = 64). The most common resultant outcome of an adverse event was the need for revision surgery (48.8%, n = 460). The need for revision surgery was common in patients who experienced fracture (47.1%), implant migration (84.5%), infection (76.7%), and neurological complications (76.9%). Implant migration, fracture, and implant malfunction, 3 complications that are unique to decompression with an IPD as compared with traditional laminectomy, accounted for 45.9% of revisions (211/460), and revision was required in 33.0% of cases where 1 of these complications was reported (211/640). Implant malfunction made up 21.2% of Coflex complications, 47.3% of Superion complications, and 5.2% of X-Stop complications. CONCLUSIONS: The most common adverse events were implant malfunction, inadequate efficacy, implant migration, and fracture. Concerningly, these complications require revision surgery in one-third of cases when they occur. Implant-specific assessments demonstrate a high prevalence of implant malfunctions for the Coflex and Superion implants. CLINICAL RELEVANCE: Interspinous process devices introduce a new class of complications to isolated spinal decompression surgery: implant-related complications. These complications occur both intraoperatively and postoperatively, and they frequently necessitate revision surgery.

Adverse Events Associated With 3 Vitrectomy Platforms Reported to the US FDA MAUDE Database.

Purpose: To identify and describe adverse events (AEs) observed with real-world use of the following 3 vitrectomy platforms: Constellation (Alcon), Enhancing Visual Acuity (EVA, Dutch Ophthalmic Research Center), and Stellaris (Bausch + Lomb). Methods: All reports submitted to the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database between January 2010 and November 2021 that were associated with the 3 vitrectomy platforms were analyzed. Each report was reviewed for AEs or consequences and the type of complication noted. Duplicates and reports with an inadequate narrative to categorize the event were excluded. A descriptive analysis was performed for the prevalence of device-specific issues within each platform. Results: The analysis included 2534 reports (1738 Constellation, 117 EVA, 679 Stellaris). Overall, the most commonly reported complications involved the vitrectomy probe (n = 957 [37.8%]) and the central processing unit (n = 368 [14.5%]). Differences in the distribution of AEs among the platforms were noted, with vitrectomy probe issues being the most reported events for the Constellation and Stellaris and infusion issues for the EVA. Infusion issues most frequently led to reports of patient harm with the Constellation (31/1738 [1.8%]) and EVA (7/116 [6.0%]), while issues with the vitrectomy probe were reported with the Stellaris (11/679 [1.6%]). Conclusions: An analysis of real-world data in the MAUDE database highlighted the spectrum of device-specific AEs of greatest relevance to surgical practice. Familiarity with potential device complications will help minimize harm to patients.

A Data Pipeline for Enhancing Quality of MAUDE-Based Studies.

The increasing use of MAUDE reports in patient safety research highlights the importance of understanding the processing and dissemination of open-access MAUDE data. However, the absence of a structured data pipeline undermines the reproducibility and transparency of studies relying on MAUDE data. In response, we conducted a comprehensive analysis of a recent study on endoscopic clips, assessing methodologies and results. We advocate for implementing an extract, transform, and load (ETL) pipeline, utilizing openFDA and integrating keyword search strategies and data visualization techniques. This approach aims to enhance the quality of MAUDE-based studies, ensuring their reproducibility and transparency. Moreover, ETL serves as a cornerstone in data engineering, enabling real-time data management and quality assurance, thus promoting the sustainability and collaboration of MAUDE-based patient safety research.

Adverse events related to suction electrocautery devices in adenotonsillectomy: Analysis of the MAUDE database.

OBJECTIVE: To identify adverse events (AEs) related to suction electrocautery use during adenotonsillectomy. METHODS: The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was searched using the terms "suction cautery," "suction electrocautery," "suction Bovie," and "suction coagulator" from January 2014 to December 2023. RESULTS: 165 AE reports were gathered from the MAUDE database medical device reports (MDRs). 36 met inclusion criteria. Patient injuries were found in 22 (61.1 %) reports and device malfunction events were found in 14 (38.9 %) reports. All patient injuries were thermal burns (N = 22, 100 %). Location of burn injuries included the lip (N = 6, 27.3 %), oral commissure (N = 5, 22.7 %), and tongue (N = 4, 18.2 %). The most common cause of an AE was inadequate device insulation (N = 7, 19.4 %). CONCLUSION: The suction electrocautery apparatus may malfunction and cause patient burn injuries. Device failures mainly result from inadequate device insulation, coagulation problems, and detachment of device components. Surgeons must be aware of these potential complications and counsel parents and patients regarding AEs.

Complications Associated with AMBU™ Scope Use: An FDA MAUDE Analysis.

Ambu® aScope™ is a disposable flexible videoscope used for a wide range of medical procedures. However, adverse events associated with this device can occur. The Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was explored for patient-related adverse events associated with Ambu® aScope™ use between January 1, 2000 and December 15, 2023. Search terms included "Ambu" and "Ascope." Thirty unique adverse events were identified. Twenty-one of the events were associated with patient injury, and 9 with device malfunction. Eight patient-reported problems were documented as foreign bodies, 3 events as airway obstruction, desaturation, or hypoxic events, and 1 event as anxiety/cardiac arrest. The remaining 18 reported insufficient information other than associated with patient injury. We found that Ambu® aScope™ flexible nasolaryngoscopes and bronchoscopes are a common and effective tool for airway evaluations that may infrequently serve as a rare form of foreign body with potentially life-threatening consequences.

Catheter-related and clinical complications associated with QDOT MICROTM Ablation Catheter.

INTRODUCTION: The QDOT MICROTM Ablation Catheter is a next-generation ablation catheter that allows for high-power ablation up to 90 watts. METHODS: We aimed to assess AE associated with the QDOT MICROTM catheter using the MAUDE database. A MAUDE database search was conducted on May 25, 2024, to capture all AEs (since FDA approval) associated with this ablation catheter. RESULTS: A total of 302 AEs from November 23, 2022, to April 30, 2024, were reported including 148 (49%) catheter-related issues and 154 (51%) clinical complications. Among the catheter-related issues, physical catheter damage (74.3%, n = 110) was most common, followed by communication or display issue (10.8%, n = 16), irrigation issue (9.5%, n = 14), signal issue or artifact (3.4%, n = 5), and inaccurate temperature measurement (2.0%, n = 3). Regarding clinical complications, the most common AE was pericardial effusion (43.5%, n = 67), followed by char formation (11.7%, n = 18), catheter thrombosis (7.1%, n = 11), stroke (7.1%, n = 11), pericarditis (7.1%, n = 11), esophageal complications (6.5%, n = 10), phrenic nerve palsy (3.9%, n = 6), cardiac arrest (3.9%, n = 6), significant AV block (3.9%, n = 6), pulmonary vein stenosis (3.2%, n = 5), coronary artery spasm (1.3%, n = 2), and pulmonary embolism (0.6%, n = 1). There were 11 deaths (five related to esophageal complications, five related to cardiac arrest, and one related to pericardial effusion with cardiac tamponade). CONCLUSION: As high-power ablation strategy with novel ablation catheters is becoming more widely utilized, operators must be aware of potential catheter-related issues and clinical complications that may arise. More data are needed to further evaluate risks of these complications to improve the catheter's safety and efficacy.

Enhancing MAUDE Database Utility by GPT-4 and Cause-Effect Visualization.

The MAUDE database is a valuable public resource for understanding malfunctions and adverse events related to medical devices and health IT. However, its extensive data and complex structure pose challenges. To overcome this, we have developed an automated analytical pipeline using GPT-4, a cutting-edge large language model. This pipeline is intended to efficiently extract, categorize, and visualize safety events with minimal human annotation. In our analysis of 4,459 colonoscopy reports from MAUDE (2011-2021), the events were categorized into operational, human factor, and device-related. Ishikawa diagrams visualized a subset stored in a vector database for easy retrieval and comparison through a similarity search. This innovative approach streamlines access to vital safety insights, reducing the workload on human annotators, and holds promise to enhance the utility of the MAUDE database.

Symbolic model checking quantum circuits in Maude.

This article presents a symbolic approach to model checking quantum circuits using a set of laws from quantum mechanics and basic matrix operations with Dirac notation. We use Maude, a high-level specification/programming language based on rewriting logic, to implement our symbolic approach. As case studies, we use the approach to formally specify several quantum communication protocols in the early work of quantum communication and formally verify their correctness: Superdense Coding, Quantum Teleportation, Quantum Secret Sharing, Entanglement Swapping, Quantum Gate Teleportation, Two Mirror-image Teleportation, and Quantum Network Coding. We demonstrate that our approach/implementation can be a first step toward a general framework to formally specify and verify quantum circuits in Maude. The proposed way to formally specify a quantum circuit makes it possible to describe the quantum circuit in Maude such that the formal specification can be regarded as a series of quantum gate/measurement applications. Once a quantum circuit has been formally specified in the proposed way together with an initial state and a desired property expressed in linear temporal logic (LTL), the proposed model checking technique utilizes a built-in Maude LTL model checker to automatically conduct formal verification that the quantum circuit enjoys the property starting from the initial state.

A Comprehensive Analysis of Reported Adverse Events and Device Failures Associated with Esophageal Self-Expandable Metal Stents: An FDA MAUDE Database Study.

INTRODUCTION: Esophageal Stents are used to maintain esophageal lumen patency in esophageal strictures caused by intrinsic and/or extrinsic malignancies and the occlusion of concomitant esophageal fistulas. While data on the efficacy and safety of esophageal stents exist, comprehensive evaluation of adverse events is limited. The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS. Pooled numbers and percentages were calculated for each adverse event. Continuous variables underwent analysis using a two-tailed student t test, and significance was set to p ≤ 0.05. RESULTS: During the study period, 548 MAUDE reports revealed 873 device failures and 186 patient-related adverse events. The most common device issues were stent activation, positioning, or separation problems (4 n = 403; 46.2%), followed by device detachment or migration (n = 109, 12.5%), and material problems (n = 93, 10.7%). Patient complications included dysphagia/odynophagia (10%), perforation, pain, and bleeding (each 7.6%). The most common device failures in over-the-wire (OTW) stents and through-the-scope (TTS) stents were activation, positioning, or separation problems (TTS: n = 183, 52.6% vs OTW: n = 220, 41.9%). Compared to OTW stents, TTS stents had higher migration and breakage (13.5% vs. 11.8%, p = 0.24), and (9.2% vs. 6.7%, p = 0.08) respectively, while OTW stents had more challenges with stent advancement or removal (5.1% vs. 0.3%, p < 0.001 and 4.6% vs 3.4%, p = 0.19, respectively) and material problems (14.7% vs. 4.6%, p < 0.001). Activation, positioning, and separation problems were the most frequent device failures in fully covered (FC) and partially covered (PC) stents (FC: n = 62, 32.8%, PC: n = 168, 43.5%). FC stents had higher migration rates (20.6% vs 9.8%, p < 0.001), while PC stents exhibited more material problems (17.4% vs. 5.8%, p < 0.001) and difficulties with advancing the stents (6.7% vs. 0%, p < 0.001). CONCLUSION: Our examination showed a prevalence of reported device complications associated with stent activation, positioning, and separation problems. Dysphagia or odynophagia emerged as the most frequently reported patient complication. Furthermore, our analysis, provides insights into TTS vs. OTW and FC vs. PC esophageal SEMSs, enabling endoscopists and manufacturers to better understand adverse events and potentially optimize device design for future iterations.

Auditory brainstem implants: an analysis of adverse events in the MAUDE database.

OBJECTIVE: Auditory Brainstem Implants (ABI) are used to restore hearing in patients lacking appropriate cochlear anatomy and/or cochlear nerve. The objective of this study was to examine the Manufacture and User Facility Device Experience (MAUDE) database to analyze adverse events. STUDY DESIGN: This is a study of a multi-institutional database maintained by the US FDA. SETTING: A database analysis was performed via collaboration of multiple clinicians at tertiary referral centers. METHODS: The MAUDE database was queried for Medical Device Reports (MDRs) relating to ABIs. MDRs were identified using the advanced search term "Implant, Auditory Brainstem" and reviewing all reports with the basic search term "Brainstem Implant". All collected reports were individually reviewed. RESULTS: A total of 265 individual patient reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding audiologic outcome included failure to provide hearing benefit (n = 27), implant failure/device malfunction (n = 10), and device non-use (n = 6). Postoperative complications included local skin infection (n = 3), CSF leak (n = 3), elevated ICP (n = 1), surgical site dehiscence (n = 1), swelling (n = 1), seroma formation requiring drainage (n = 1), and meningitis (n = 2). Two patients had dislodged magnets during 1.5 Tesla MRI acquisition. There were 35 instances of full explantation of the device and 1 partial removal; 13 patients had a new device implanted following explantation. CONCLUSIONS: Poor hearing results, device failure, and non-use were commonly reported causes for explanation in this analysis. This information can aid physicians in counseling patients and family members and managing device expectations.

Adverse Events and Device Failures Associated with Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database.

INTRODUCTION: Pancreatic duct stents (PDS) are widely used for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, there is a paucity of data regarding the adverse events associated with PDS placement. This study aims to investigate the reported adverse events and device failures related to PDS, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA). METHODS: Post-marketing surveillance data from January 2013 to December 8, 2023, were extracted from the FDA's MAUDE database to analyze the reports pertaining to the use of commonly used PDS. The primary outcomes of interest were device issues and patient-related adverse events. Statistical analysis was performed using Microsoft Excel 2010, with the calculation of pooled numbers and percentages for each device and patient adverse event. RESULTS: A total of 579 device issues and 194 patient-related adverse events were identified. Device issues were primarily attributed to stent deformation (n = 72; 12.4%), followed by migration of the device into the pancreatic duct or expulsion out of the duct (n = 60; 10.4%), and stent fracture/breakage (n = 55; 9.4%). Among the patient-reported adverse events, inflammation was the most common (n = 26; 13.4%), followed by reports of stents becoming embedded in tissue (n = 21; 10.8%) and stent occlusion/obstruction (n = 16; 8.2%). The most prevalent device failures associated with Advanix stents were material deformation, with perforation (n = 3, 30%) being the most frequently reported adverse event. Concerning Geenen stents, migration or expulsion of the device (n = 34, 16.9%) constituted the most common device-related adverse events, while inflammation (n = 20, 16.7%) was the most frequently reported patient-related issue. For Zimmon stents, migration or expulsion of the device (n = 22, 8.8%) were the most frequently reported device-related problems, whereas perforation (n = 7, 10.9%) and bleeding (n = 7, 10.9%) were the most frequent patient-related adverse events. CONCLUSION: Our findings highlight important device and patient adverse events that endoscopists and referring providers should be aware of before considering pancreatic stent placement.

Adverse events associated with Vibrant Soundbridge: A MAUDE study.

OBJECTIVE: To summarize adverse events and their root causes reported to the United States Food and Drug Administration (FDA) on Vibrant Soundbridge (VSB) hearing device (Med-El, Innsbruck, Austria), an active middle ear implant for patients with moderate to severe hearing loss. MATERIALS AND METHODS: The FDA's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of VSB adverse events from January 1, 2012, to July 27, 2022. RESULTS: Six hundred sixty-three total medical device reports were identified, from which 913 adverse events were extracted. Of these, 498 (54.5 %) were adverse events to patients (AEPs), while 415 (45.5 %) were device malfunctions (DMs). The most common AEPs were hearing performance issues 428 (85.9 %). The most common DMs were compromised conductive link 125 (30.1 %). Root causes identified for DMs were iatrogenic 85 (58.6 %), patient-related 28 (19.3 %), and trauma and external causes 32 (22.1 %). The most common iatrogenic root cause 12 (14.1 %) involved damage to the conductive link during revision surgery. The most common patient-related causes of DMs were excessive middle ear tissue growth 16 (57 %), and abrupt body movements 5 (28.6 %). The most common external cause of DM was cleaning of the ear canal or mastoid cavity 20 (62.5 %). CONCLUSIONS: Despite its well-known limitations, the MAUDE database provides valuable information on possible complications of VSB as it relates to device malfunction or adverse events for patients. Implementation of standardized reports with relevant and well-defined categories could certainly allow for a more meaningful analysis.

Adverse events associated with device assisted hyoid and tongue base suspension for obstructive sleep apnea.

PURPOSE: Hyoid and tongue base suspension may treat obstructive sleep apnea (OSA). This study summarizes device-related adverse events associated with the AIRvance and AIRLIFT systems used for hyoid and tongue base suspension. MATERIALS AND METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports describing adverse events associated with hyoid or tongue base suspension from January 2012 to December 2022. RESULTS: 77 adverse events were identified. When performed separately, adverse events were equally as common with hyoid suspension as with tongue base suspension. More complications occurred postoperatively (51 [66.2 %]) than intraoperatively (26 [33.8 %]). The most reported adverse events were infection (23 [29.9 %]), broken screw (15 [19.5 %]), pain or discomfort (10 [13.0 %]), suture rupture (8 [10.4 %]), and dislodged screw (7 [9.1 %]). 10 infections required drainage or debridement; 12 required device explantation. CONCLUSIONS: The present study is the largest and most longitudinal review of adverse events associated with hyoid and tongue base suspension. Infection was the most common adverse event, and may require device explantation. While adverse events were most frequently attributed to device malfunction, broken screw, suture rupture, and broken needle were often attributed to operator error due to application of excessive force. Surgeon training to increase familiarity with hyoid and tongue base suspension may reduce adverse events caused by operator error. The MAUDE database is limited as a passive surveillance system. Standardized reporting may improve understanding of associated adverse events, enabling better informed comparisons between surgical treatment options for OSA.

Medical device report analyses from MAUDE: Device and patient outcomes, adverse events, and sex-based differential effects.

Post-market medical device-associated failures and patient problems are reported in Medical Device Reports (MDRs) to the US Food and Drug Administration. Reports are accessible through Manufacturer and User Facility Device Experience (MAUDE), a database including both required and voluntary submissions. We present an overview of >10 million MDRs received from 2011 to 2021. Approximately 92% of reporting issues represent medical device physical or functional failures, categorized from 1704 codes related to medical device integrity or function. ∼8% were coded adverse events (AEs). Patient outcomes are reported via 998 patient codes in 19 medical specialties (cardiovascular, orthopedic, etc.). ∼40% of patient reports indicated "no health consequences"; however, a small number of devices had consistently high AE reports. While overall reports did not exhibit a sex-based dichotomy, ∼9% of the reported AEs occurred more frequently in females, many of which were related to immune effects. The analyses are subject to uncertainties and potential bias based on data available and data selected for analysis. However, such an overview of post-market MDR data, not previously published, fills a gap in understanding medical device issues and patient-based outcomes related to medical device use. Trends identified may be subjects of additional hypotheses, analysis, and research.