MEDTRONIC TRANSCATHETER VALVE Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR)
Total Reports
1,164
Reports (30d)
16
Active Signals
1
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Literature Batch: Self-Expanding Valve Outcomes
devices, evolut, patients, study, included
34
reports
Deployment Issues with Delivery Catheter
deployment, dcs, catheter dcs, balloon, delivery catheter
3
reports
Complete Heart Block Two Days Post-Implant
block, pacemaker, heart block, complete, implant transcatheter
1
reports
Left Bundle Branch Block Post-Implant
branch block, bundle branch, bundle, branch, block
1
reports
Valve Failure Due to Paravalvular Leak
leak pvl, failed, pvl, paravalvular leak, 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
Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves
Sabine Bleiziffer, et al. · European Heart Journal · 2020
Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial
Hans Gustav Hørsted Thyregod, et al. · European Heart Journal · 2024
Transcatheter Valve-in-Valve Aortic Valve Replacement as an Alternative to Surgical Re-Replacement
Pierre Deharo, et al. · Journal of the American College of Cardiology · 2020
Transfemoral transcatheter aortic valve replacement without contrast medium using the Medtronic CoreValve system: a single center experience
Diego Maffeo, et al. · The Journal of Cardiovascular Surgery · 2020
Citations indexed from PubMed.
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