MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2014 · 12 device variants grouped
Total Reports
4,236
Reports (30d)
33
Active Signals
11
Open Recalls
3
What the reports describe · Claripulse analysis
Valve Failure Due to Stenosis After 7 Years
approximately years, years months, following implant, implant transcatheter, years
36
reports
Structural Valve Deterioration After 2.5 Years
tav, bioprosthetic, implant transcatheter, bioprosthetic valve, years
15
reports
Paravalvular Leak Identified Post-Deployment
deployment, dcs, non medtronic, implant transcatheter, balloon
13
reports
Valve Dislodgement During Retrieval
gradient, leak, non medtronic, bioprosthetic, evolut
7
reports
Moderate to Severe Paravalvular Leak Post-Implant
gradient, regurgitation, implant transcatheter, mmhg, mean
5
reports
Valve Failure for Unknown Reason After 6 Years
years months, approximately years, following implant, implant transcatheter, months
4
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
Leaflet disruption of ViV-TAVI after bioprosthetic valve fracture leading to severe aortic regurgitation: a case report
E. Ballout, et al. · European Heart Journal - Case Reports · 2022
Propensity-Matched Analysis of Early and Long-Term Clinical Outcomes with Self-Expandable Prostheses in TAVR: Portico vs. CoreValve Evolut R.
Primessnig U, et al. · 2025
Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis
Corrado Tamburino, et al. · Circulation · 2020
Transcatheter aortic valve replacement in heavily calcified aortic valve stenosis: a multicenter comparison.
Saad M, et al. · 2025
Performance of the CoreValve Evolut R and PRO in Severely Calcified Anatomy: A Propensity Score Matched Analysis
Kerstin Piayda, et al. · Heart Lung and Circulation · 2020
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. 11 active signals detected right now.
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