WATCHMAN Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Left Atrial Appendage Closure · First cleared Mar 2015
Total Reports
3,844
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Post-Implant Pericardial Effusion
effusion noted, pericardiocentesis performed, perforation, pericardiocentesis, effusion occurred
4
reports
Device Embolization Post-Implant
atrial pressure, attempts, embolized, device did, transferred
3
reports
Device-Related Thrombosis at Follow-Up
related thrombus, discharged routine, drt, thrombosis occurred, reported thrombosis
3
reports
Literature Batch: Long-Term Death Outcomes
corresponding, included study, disease, group, included
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Clinical outcomes of Watchman vs. Amplatzer occluders for left atrial appendage closure (WATCH at LAAC)
Caroline Kleinecke, et al. · EP Europace · 2020
Contemporary procedural trends of Watchman percutaneous left atrial appendage occlusion in the United States
Muhammad Bilal Munir, et al. · Journal of Cardiovascular Electrophysiology · 2020
Citations indexed from PubMed.
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