Evolut PRO Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2014 · 14 device variants grouped
Total Reports
7,758
Reports (30d)
103
Active Signals
5
Open Recalls
3
What the reports describe · Claripulse analysis
Most commonly reported problems
Infection-Related Death Post-ImplantEmerging
related, registry, following implant, provided, post implant
9
reports
RA Lead High Capture Thresholds
months following, following implant, years months, valve failed, years
84
reports
Structural Valve Deterioration After Five Years
approximately years, following implant, tav, bioprosthetic, years
14
reports
Paravalvular Leak Five Years Post-Implant
leak pvl, months following, following implant, pvl, years
9
reports
Constrained Valve Deployment After BAV
aortic valvuloplasty, dcs, bav, balloon aortic, balloon
6
reports
Infolding Observed During Deployment Attempt
deployment, attempted, recaptured, attempt, delivery catheter
5
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
Self-Expandable Transcatheter Aortic Valve Frame Infolding: An Increasingly Recognized Complication
Gurpreet Singh, et al. · European Journal of Case Reports in Internal Medicine · 2020
<scp>Redo‐transcatheter</scp> aortic valve replacement with the <scp>supra‐annular</scp>, <scp>self‐expandable</scp> Evolut platform: Insights from the <scp>Transcatheter valve Therapy</scp> Registry
Guilherme F. Attizzani, et al. · Catheterization and Cardiovascular Interventions · 2021
Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study
Ganesh Manoharan, et al. · EuroIntervention · 2020
Successful Treatment of Severe Paravalvular Leak by Repositioning a Self-Expandable Percutaneous Aortic Valve Bioprosthesis (Evolut PRO+) Using the “Double Snare” Technique
Diego H. González-Bravo, et al. · Case Reports in Cardiology · 2022
Conduction Disturbances and Permanent Pacemaker Implantation After TAVR With Self-Expanding Devices: The CONNAVIPRO Study.
Poletti E, et al. · Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
Citations indexed from PubMed.
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