MEDTRONIC TRANSCATHETER VALVE Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR)
Total Reports
1,109
Reports (30d)
22
Active Signals
1
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Literature Batch: TAVR Clinical Outcomes
evolut, patients, study, tavi, included
47
reports
Valve Failure Due to Unspecified Regurgitation
months following, approximately years, years months, following implant, implant transcatheter
6
reports
Unspecified Conduction Disturbance with Pacemaker
unspecified, pacemaker implanted, conduction, implant transcatheter, permanent pacemaker
3
reports
Complete Heart Block Requiring Pacemaker
block, pacemaker, pacemaker implanted, complete, permanent pacemaker
2
reports
Literature Batch: TAVR Complications
replacement tavr, non medtronic, evolut, valve replacement, underwent
2
reports
Severe Aortic Regurgitation After PVL
following implant, implant transcatheter, paravalvular, pvl, paravalvular leak
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.
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