CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
995
Reports (30d)
3
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Explanted Aortic Valve for Unknown Reasons
device learned, aortic valve, explanted valve, learned implant, patient aortic
2
reports
Severe Aortic Regurgitation Post-Implant
transcatheter valve, adverse, valve valve, effects, transcatheter
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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