CoreValve Evolut Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2014 · 13 device variants grouped
Total Reports
4,432
Reports (30d)
26
Active Signals
2
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
RA Lead High Capture Thresholds
months following, following implant, years months, valve failed, years
37
reports
Structural Valve Deterioration After Five Years
approximately years, following implant, tav, bioprosthetic, years
36
reports
Moderate PVL and Atrial Fibrillation Post-Implant
included, block, history, showed, evolut
8
reports
Paravalvular Leak Five Years Post-Implant
leak pvl, months following, following implant, pvl, years
6
reports
Literature Batch: Self-Expanding Valve Outcomes
evolut, patients, study, tavi, included
4
reports
Unspecified Death Months Post-Implant
months following, years months, following implant, tav, years
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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.
Evidence
Related research
Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis
Corrado Tamburino, et al. · Circulation · 2020
Propensity-Matched Analysis of Early and Long-Term Clinical Outcomes with Self-Expandable Prostheses in TAVR: Portico vs. CoreValve Evolut R
Uwe Primeßnig, et al. · Journal of Clinical Medicine · 2025
Impact of Transcatheter or Surgical Aortic Valve Performance on 5-Year Outcomes in Patients at ≥ Intermediate Risk
Steven J. Yakubov, et al. · Journal of the American College of Cardiology · 2025
Permanent pacemaker implantation and left bundle branch block with self-expanding valves – a SCOPE 2 subanalysis
Costanza Pellegrini, et al. · EuroIntervention · 2023
Transcatheter aortic valve replacement in heavily calcified aortic valve stenosis: a multicenter comparison
Mohammed Saad, et al. · Clinical Research in Cardiology · 2025
Citations indexed from PubMed.
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