Adverse Events Involving Radiation Oncology Medical Devices: Comprehensive Analysis of US Food and Drug Administration Data, 1991 to 2015.

PURPOSE: Radiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non-radiation oncology devices. METHODS AND MATERIALS: MAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. RESULTS: There were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001). CONCLUSIONS: Compared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved software design, and manufacturer-user training may help mitigate these events.

Use of a percutaneous arterial suture device (Perclose) in patients undergoing percutaneous balloon aortic valvuloplasty.

Percutaneous balloon aortic valvuloplasty has been used as a therapeutic option for patients with severe aortic stenosis who are not candidates for aortic valve replacement. This procedure has been limited by both the high rate of aortic valve restenosis and high procedural morbidity related chiefly to the large femoral arteriotomies required. The purpose of this study was to assess the feasibility and vascular complication rate using the "Preclose" technique in patients undergoing balloon aortic valvuloplasty. We evaluated the immediate and 30-day results in 18 consecutive patients undergoing this procedure. Angiographically significant peripheral vascular disease was present in 39% of cases. Aortic balloon dilation produced significant decreases in the mean aortic valve pressure gradient from 55 +/- 20 mmHg to 30 +/- 22 mmHg (P < 0.001). Closure of the arteriotomy with an 8F (10F in 1 case) Perclose device led to immediate hemostasis in all patients. Perclose of the contralateral femoral arterial site with a 6F device was attempted in 50%, all of which were successful. The mean length of bed rest was 4.5 +/- 0.9 hr. No procedural was observed. No patient had a local vascular complication, and no patient required blood product transfusion after the procedure. The use of the "Preclose" technique for closure of femoral arteriotomies after balloon aortic valvuloplasty is feasible and associated with a low rate of periprocedural and short-term vascular complications.