WATCHMAN Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Left Atrial Appendage Closure · First cleared Mar 2015 · 5 device variants grouped
Total Reports
4,722
Reports (30d)
14
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device-Related Thrombus at Follow-Up
thrombosis occurred, cerebral vascular, cerebral, accident, related thrombus
11
reports
Pericardial Effusion Post-Deployment
effusion cardiac, tamponade, perforation, pericardiocentesis, effusion occurred
9
reports
Device Embolization Two Hours Post-Implant
air, attempts, curve, device embolization, embolized
6
reports
Patient Death Following Procedure
events, long term, data, involved, death occurred
4
reports
Device Migration with Peri-Device Leak
wire, did seal, core wire, device leak, seal left
3
reports
Literature Batch: LAAO Safety Comparison
average age, corresponding, research, included study, average
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Watchman device migration and embolization: A report from the NCDR LAAO Registry
Daniel J. Friedman, et al. · Journal of Cardiovascular Electrophysiology · 2023
Safety and efficacy of Watchman extraction using a double transseptal approach
Marco Marino, et al. · Heart Rhythm · 2026
Watchman FLX vs. Watchman 2.5 in a Dual-Center Left Atrial Appendage Closure Cohort: the WATCH-DUAL study
Roberto Galea, et al. · EP Europace · 2022
Comparison in Short-Term Safety and Efficacy between New-Generation WATCHMAN FLX and Conventional WATCHMAN 2.5 for Percutaneous Left Atrial Appendage Closure
Nobuyuki Fukuda, et al. · Journal of Clinical Medicine · 2022
Utilization and procedural adverse outcomes associated with Watchman device implantation
Fouad M. Khalil, et al. · EP Europace · 2020
Citations indexed from PubMed.
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