CoreValve Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2014
Total Reports
794
Reports (30d)
25
Active Signals
2
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Infection-Related Death Post-ImplantEmerging
related, registry, following implant, provided, post implant
1
reports
RA Lead High Capture Thresholds
months following, following implant, years months, valve failed, years
5
reports
Structural Valve Deterioration After Five Years
approximately years, following implant, tav, bioprosthetic, years
5
reports
Literature Batch: Self-Expanding Valve Outcomes
evolut, patients, study, tavi, included
4
reports
Paravalvular Leak Five Years Post-Implant
leak pvl, months following, following implant, pvl, years
1
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
Recapture failure in transcatheter aortic valve replacement with <scp>CoreValve</scp> Evolut R
Nobuyasu Ito, et al. · Catheterization and Cardiovascular Interventions · 2021
CoreValve vs. Sapien 3 Transcatheter Aortic Valve Replacement: A Finite Element Analysis Study
Francesco Nappi, et al. · Bioengineering · 2021
Five-Year Clinical and Quality of Life Outcomes From the CoreValve US Pivotal Extreme Risk Trial
Suzanne V. Arnold, et al. · Circulation Cardiovascular Interventions · 2021
Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR
David G. Rizik, et al. · JAMA Network Open · 2022
Citations indexed from PubMed.
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