CARPENTIER-EDWARDS BIOPROSTHESIS - MITRAL Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
3,239
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Severe Stenosis After Long-Term Implant
condition, explanted implant, duration years, severe stenosis, explanted
10
reports
Registry-Based Device Explant Notification
devices, patient registry, implant patient, registry, registry registry
4
reports
Device Explant Without Replacement Reason
medtronic received, replacement reported, explanted replaced, valve explanted, reason replacement
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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