Evolut PRO Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Mar 2017 · 14 device variants grouped
Total Reports
7,814
Reports (30d)
56
Active Signals
4
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Deployment Issues with Delivery Catheter
deployment, dcs, catheter dcs, balloon, delivery catheter
41
reports
Valve Failure After Six Years
failed, approximately years, years months, implant transcatheter, years
32
reports
Severe Central Regurgitation After Seven Years
moderate, regurgitation, years months, second, mild
11
reports
Valve Failure Due to Severe Regurgitation
failed, regurgitation, following implant, approximately years, implant transcatheter
10
reports
Valve Failure Due to Paravalvular Leak
leak pvl, failed, pvl, paravalvular leak, years
9
reports
Valve Explantation After Six Years
years months, following implant, implant transcatheter, months, explanted
7
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
The Latest Evolution of the Medtronic CoreValve System in the Era of Transcatheter Aortic Valve Replacement: Matched Comparison of the Evolut PRO and Evolut R.
Hellhammer K, et al. · JACC. Cardiovascular interventions · 2018
Evolut PRO/PRO+ versus Evolut R system for transcatheter aortic valve replacement
Sukhdeep Singh Bhogal, et al. · International Journal of Cardiology · 2023
Redo-Transcatheter Aortic Valve Replacement With Self-Expanding Valves: A U.S. Registry Analysis.
Rogers T, et al. · JACC. Cardiovascular interventions · 2026
Early Real-World Experience with CoreValve Evolut PRO and R Systems for Transcatheter Aortic Valve Replacement.
Rao G, et al. · Journal of interventional cardiology · 2019
Redo‐transcatheter aortic valve replacement with the supra‐annular , self‐expandable Evolut platform: Insights from the Transcatheter valve Therapy Registry
Guilherme Ferragut Attizzani, et al. · Catheterization and Cardiovascular Interventions · 2021
Citations indexed from PubMed.
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