EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2014
Total Reports
1,350
Reports (30d)
3
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Valve-in-Valve Procedure for HALT
sapien ultra, resilia valve, resilia, ultra resilia, ultra
17
reports
Registry Report: Cardiac Perforation Injuries
events, registry, injury, sapien ultra, thv
2
reports
Registry Report: Valve Explant After TAVR
registry, transfemoral, procedure sapien, tavr procedure, explanted
1
reports
Valve Failure Due to Unspecified Regurgitation
months following, approximately years, years months, following implant, implant transcatheter
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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