SAPIEN 3 Ultra RESILIA Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015
Total Reports
322
Reports (30d)
19
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
28
reports
Registry Report: Valve Explant Without Cause
valve aortic, aortic position, registry, ultra, explanted
10
reports
Registry Report: Valve Explant After TAVR
registry, transfemoral, procedure sapien, tavr procedure, explanted
3
reports
Registry Report: Valve Explant Unknown Cause
reported edwards, aortic position, registry, procedure sapien, valve replacement
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
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