CoreValve Evolut Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2014 · 13 device variants grouped
Total Reports
4,492
Reports (30d)
36
Active Signals
0
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Valve Failure After Six Years
failed, approximately years, years months, implant transcatheter, years
17
reports
Valve Failure Due to Severe Regurgitation
failed, regurgitation, following implant, approximately years, implant transcatheter
9
reports
Literature Batch: Self-Expanding Valve Outcomes
devices, evolut, patients, study, included
6
reports
Severe Central Regurgitation After Seven Years
moderate, regurgitation, years months, second, mild
6
reports
Calcified Leaflets Detected Months Later
left, related, bioprosthetic, months, years
5
reports
Valve Failure Due to Paravalvular Leak
leak pvl, failed, pvl, paravalvular leak, years
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Jun 11, 2021 · Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Jun 11, 2021 · Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
Jun 11, 2021 · Open, Classified
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
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