CARPENTIER-EDWARDS BIOPROSTHESIS - AORTIC Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
784
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Registry-Based Device Explant Notification
devices, patient registry, implant patient, registry, registry registry
1
reports
Severe Stenosis After Long-Term Implant
condition, explanted implant, duration years, severe stenosis, 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
Carpentier-Edwards Magna Ease bioprosthesis: a multicentre clinical experience and 12-year durability
Antonio Piperata, et al. · European Journal of Cardio-Thoracic Surgery · 2021
Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis
Krzysztof Bartuś, et al. · European Journal of Cardio-Thoracic Surgery · 2020
Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis
Thomas M. Beaver, et al. · Journal of Thoracic and Cardiovascular Surgery · 2023
Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement
Troels Højsgaard Jørgensen, et al. · European Heart Journal · 2021
Citations indexed from PubMed.
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