CARPENTIER-EDWARDS BIOPROSTHESIS - MITRAL Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
3,256
Reports (30d)
2
Active Signals
0
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
Calcification-Induced Valve-in-Valve Procedure
procedure implant, valve procedure, implant duration, duration years, presented
3
reports
Degeneration Leading to Valve-in-Valve Replacement
mitral position, medical article, implanted mitral, position underwent, bioprosthesis
3
reports
Explanted Valve After Extended Implant Duration
registry, explanted implant, implant duration, valve explanted, explanted
3
reports
Valve Explanted During Implant Procedure
adverse, medtronic received, effects, explanted replaced, valve explanted
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Comparison of porcine versus bovine pericardial bioprosthesis in the mitral position
Hideki Tsubota, et al. · Journal of Cardiac Surgery · 2021
Bioprosthesis in the Mitral Position: Bovine Pericardial versus Porcine Xenograft
Dong Youb Han, et al. · The Korean Journal of Thoracic and Cardiovascular Surgery · 2022
One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Transcatheter Heart Valve
Brian K. Whisenant, et al. · JAMA Cardiology · 2020
Citations indexed from PubMed.
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