WATCHMAN FLX Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Left Atrial Appendage Closure · First cleared Mar 2015
Total Reports
822
Reports (30d)
3
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Migration with Peri-Device Leak
seal left, discharged routine, did seal, shifted, leak occurred
3
reports
Device-Related Thrombosis at Follow-Up
related thrombus, discharged routine, drt, thrombosis occurred, reported thrombosis
3
reports
Cerebral Vascular Accident Post-Implant
vascular accident, cerebral vascular, tomography scan, leak occurred, accident
2
reports
Device Embolization Post-Implant
atrial pressure, attempts, embolized, device did, transferred
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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