CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
1,152
Reports (30d)
5
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
2
reports
Explanted Aortic Valve for Unknown Reasons
device learned, aortic valve, explanted valve, learned implant, patient aortic
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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