MEDTRONIC TRANSCATHETER VALVE Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR)
Total Reports
1,173
Reports (30d)
41
Active Signals
1
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
4
reports
Literature Batch: Self-Expanding Valve Outcomes
evolut, patients, study, tavi, included
36
reports
RA Lead High Capture Thresholds
months following, following implant, years months, valve failed, years
6
reports
Structural Valve Deterioration After Five Years
approximately years, following implant, tav, bioprosthetic, years
3
reports
Complete Heart Block One Day Post-Implant
block, pacemaker, heart block, complete, permanent pacemaker
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
Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial
Hans Gustav Hørsted Thyregod, et al. · European Heart Journal · 2024
Comparison of newer generation self-expandable vs. balloon-expandable valves in transcatheter aortic valve implantation: the randomized SOLVE-TAVI trial
Hölger Thiele, et al. · European Heart Journal · 2020
Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves
Sabine Bleiziffer, et al. · European Heart Journal · 2020
Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research
Philippe Généreux, et al. · Journal of the American College of Cardiology · 2021
Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research
Philippe Généreux, et al. · European Heart Journal · 2020
Citations indexed from PubMed.
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