Evolut FX Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2014 · 14 device variants grouped
Total Reports
13,556
Reports (30d)
256
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
363
reports
Heart Failure Deaths Post-Implant
related, registry, procedure patient, provided, implant procedure
23
reports
Damaged Valve Packaging Prior to Implant
bioprosthetic, prior, successfully, valve implantation, used
22
reports
Death Two Months Post-Implant
artery, following implant, bioprosthetic, implant transcatheter, months
20
reports
Complete Heart Block Two Days Post-Implant
block, pacemaker, heart block, complete, implant transcatheter
19
reports
Cerebral Infarction Following Implant
following implant, bioprosthetic, implant transcatheter, presented
18
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
Transcatheter Paravalvular Leak Closure Using Valve Frame Access
Chloé Kharsa, et al. · JACC Case Reports · 2026
Transcatheter Aortic Valve Replacement in a Failed Homograft
Maximilian Reisinger, et al. · JACC Case Reports · 2026
Redo‐Transcatheter Aortic Valve Replacement With a 26 mm Sapien Valve in a 26 mm Evolut Valve to Correct Significant Paravalvular Leak via Transcarotid Access
Charlene L. Rohm, et al. · Catheterization and Cardiovascular Interventions · 2025
Nordic consensus document on Evolut FX+ transcatheter aortic valve implantation: optimizing index implantation and longer-term outcomes
Arif Azhar Khokhar, et al. · Frontiers in Cardiovascular Medicine · 2025
Design and rationale of the COMPARE-TAVI 2 trial: An all-comers head-to-head comparison of Evolut FX+ and Sapien 3 Ultra Resilia transcatheter heart valves.
Thim T, et al. · American heart journal · 2026
Citations indexed from PubMed.
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