MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2014
Total Reports
761
Reports (30d)
0
Active Signals
1
Open Recalls
3
What the reports describe · Claripulse analysis
Paravalvular Leak Identified Post-Deployment
deployment, dcs, non medtronic, implant transcatheter, balloon
2
reports
Literature Batch: TAVR Clinical Outcomes
devices, evolut, patients, study, included
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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
CoreValve vs. Sapien 3 Transcatheter Aortic Valve Replacement: A Finite Element Analysis Study
Francesco Nappi, et al. · Bioengineering · 2021
Recapture failure in transcatheter aortic valve replacement with <scp>CoreValve</scp> Evolut R
Nobuyasu Ito, et al. · Catheterization and 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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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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