CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS - MITRAL Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
484
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Aortic Valve Stenosis Leading to Explant
valve valve, severe, aortic valve, learned, valve procedure
1
reports
Explanted Mitral Valve After 5 Years
device learned, reasons explanted, mitral valve, explanted valve, learned implant
1
reports
Template Summary: Implant Patient Registry
implanted replacement, valve model, registry ipr, model implanted, ipr registry
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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