Edwards SAPIEN 3 Ultra Transcatheter Heart Valve Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015
Total Reports
13,682
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Balloon Rupture During Valve-in-Valve Procedure
ultra, clinical specialist, specialist, sapien ultra, resilia valve
254
reports
Valve Explantation After Long-Term Implant
implant patient, aortic position, registry, sapien ultra, explanted
32
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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