Adverse Events After Left Atrial Appendage Closure: Lessons Learned From the Manufacturer and User Facility Device Experience (MAUDE) Database.

Left atrial appendage (LAA) closure devices are alternative treatments recently approved for patients with atrial fibrillation. Due to the novelty of these devices, limited postapproval surveillance data on LAA closure devices have been published. Thus, we analyzed the United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to report these findings. The primary endpoint was final event outcome, and secondary endpoints included management strategies of reported events.