CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
917
Reports (30d)
6
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Template Summary: Registry Explant Notification
devices, patient registry, implant patient, registry, registry registry
6
reports
Explanted Valve After Extended Implant Duration
registry, explanted implant, implant duration, valve explanted, explanted
2
reports
Calcification-Induced Valve-in-Valve Procedure
procedure implant, valve procedure, implant duration, duration years, presented
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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