WATCHMAN Access System Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Left Atrial Appendage Closure · First cleared Mar 2015 · 3 device variants grouped
Total Reports
1,259
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Pericardial Effusion Post-Deployment
effusion cardiac, tamponade, perforation, pericardiocentesis, effusion occurred
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Real-world clinical outcomes with a next-generation left atrial appendage closure device: the FLXibility Post-Approval Study.
Betts TR, et al. · Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
Comparative Data of Procedural and Midterm Outcomes in Patients Who Underwent Percutaneous Left Atrial Appendage Closure Between the WATCHMAN FLX and WATCHMAN 2.5 Devices ― Insight From the OCEAN-LAAC Registry ―
Masaki Nakashima, et al. · Circulation Journal · 2024
Intracardiac Echocardiography to Guide Watchman FLX Implantation
Jens Erik Nielsen‐Kudsk, et al. · JACC: Cardiovascular Interventions · 2023
Rationale and design of a randomized study comparing the Watchman FLX device to DOACs in patients with atrial fibrillation
Saibal Kar, et al. · American Heart Journal · 2023
The Efficacy and Safety of the WATCHMAN Device in LAA Occlusion in Patients with Non-Valvular Atrial Fibrillation Contraindicated to Oral Anticoagulation: A Focused Review.
Majule DN, et al. · Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia · 2018
Citations indexed from PubMed.
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