Evolut FX Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Transcatheter Aortic Valve (TAVR) · First cleared Jan 2014 · 14 device variants grouped
Total Reports
13,277
Reports (30d)
353
Active Signals
2
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
22
reports
Constrained Valve Deployment After BAV
aortic valvuloplasty, dcs, bav, balloon aortic, balloon
50
reports
Conduction Disturbance Leading to Pacemaker
related, pacemaker implanted, following implant, permanent pacemaker, block
48
reports
Delivery Catheter Failure Leading to Dislodgement
advanced, dcs, deployed, catheter, delivery catheter
45
reports
RA Lead High Capture Thresholds
months following, following implant, years months, valve failed, years
34
reports
Severe Hypotension Following Pre-Implant BAV
pressure, pre implant, pre, bav, balloon
29
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
Chloe Kharsa, 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
30-Day and 1-Year Outcomes From the Optimize PRO TAVR Evolut FX Addendum Study
Hemal Gada, et al. · JACC: Cardiovascular Interventions · 2025
Clinical and haemodynamic outcomes with contemporary intra- and supra-annular self-expanding valves: the multicentre international HERA-TAVI registry
Matteo Casenghi, et al. · EuroIntervention · 2026
Nordic consensus document on Evolut FX+ transcatheter aortic valve implantation: optimizing index implantation and longer-term outcomes
Arif Khokhar, et al. · Frontiers in Cardiovascular Medicine · 2025
Citations indexed from PubMed.
Keep exploring
Related devices in Structural
MitraClip
ABBOTT VASCULAR INC. · 18,673 reports
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC · 13,682 reports
Evolut PRO
MEDTRONIC, INC. · 7,758 reports
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC · 6,164 reports
CoreValve Evolut
MEDTRONIC, INC. · 4,432 reports
WATCHMAN
BOSTON SCIENTIFIC CORPORATION · 3,844 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.
Get Early AccessUnderstanding this data