Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015
Total Reports
288
Reports (30d)
15
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Delivery System Failure During Procedure
ultra, sheath, delivery, esheath, balloon
16
reports
Valve Explantation 4 Years Post-Implant
valve aortic, aortic position, registry, months, ultra
10
reports
Valve Stenosis 9 Years Post-Implant
clinical specialist, valve valve, approximately years, field, field clinical
5
reports
Valve Explantation 3 Years Post-TAVR
registry, transfemoral, approximately years, procedure sapien, tavr procedure
4
reports
Unspecified Death 24 Days Post-Implant
unspecified, days following, following implant, implant transcatheter, death
1
reports
Moderate-to-Severe Paravalvular Leak
leak, paravalvular, pvl, paravalvular leak, ultra
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Anesthetic Management for Valve-in-Valve Transcatheter Aortic Valve Replacement (TAVR) After Primary TAVR Failure With Mixed Aortic Valve Dysfunction.
Choi J, et al. · 2025
A stuck leaflet after balloon post-dilatation in transcatheter aortic valve implantation with a SAPIEN-3 ultra RESILIA valve: a case report.
Yamazoe S, et al. · 2024
Severe intraprosthetic aortic insufficiency immediately after implantation of a SAPIEN 3 Ultra RESILIA valve with spontaneous resolution: case report.
Diaz JA, et al. · 2024
Delayed Migration of a Transcatheter Aortic Valve Into the Left Ventricular Outflow Tract.
Issany A, et al. · 2025
Valve Pop-Up and Infolding in Transcatheter Aortic Valve Replacement for a Heavily Calcified Bicuspid Valve.
Yamamoto M, et al. · 2026
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. 1 active signal detected right now.
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