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

J Invasive Cardiol. 2020 Aug;32(8):E216-E218.

Abstract

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.

Keywords: atrial fibrillation; left atrial appendage closure.

MeSH terms

  • Atrial Appendage* / diagnostic imaging
  • Atrial Appendage* / surgery
  • Atrial Fibrillation* / diagnosis
  • Atrial Fibrillation* / epidemiology
  • Atrial Fibrillation* / surgery
  • Cardiac Surgical Procedures*
  • Databases, Factual
  • Humans
  • Treatment Outcome
  • United States / epidemiology
  • United States Food and Drug Administration