Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
3,199
Reports (30d)
15
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Patient Registry: Valve Explant After 8.5 Years
patient registry, registry, registry registry, registry patient, explanted
11
reports
Valve Explant Due to Calcification and Stenosis
replaced, explanted implant, implant duration, valve explanted, explanted
10
reports
Template Summary: Implant Patient Registry Overview
patient registry, registry, data, registry ipr, ipr registry
6
reports
Transcatheter Valve-In-Valve Procedure After 17 Years
procedure implant, transcatheter valve, valve procedure, underwent valve, transcatheter
6
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Aortic Valve Replacement With Mechanical Valves vs Perimount Bioprostheses in 50- to 69-Year-Old Patients
Ruixin Lu, et al. · JACC Advances · 2023
A single-center 14-year follow-up study of the BalMedic® bovine pericardial bioprosthetic valve
Minghao Lin, et al. · Annals of Translational Medicine · 2020
Acquired discrete subaortic stenosis late after mitral valve replacement.
Mohan JC, et al. · 2016
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. 2 active signals detected right now.
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