Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
6,040
Reports (30d)
47
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Patient Registry: Valve Explant After 7 Years
patient registry, registry, registry registry, registry patient, explanted
40
reports
Valve Explant Due to Calcification and Stenosis
replaced, explanted implant, implant duration, valve explanted, explanted
22
reports
Template Summary: Implant Patient Registry Overview
patient registry, registry, data, registry ipr, ipr registry
18
reports
Transcatheter Valve-In-Valve Procedure After 17 Years
procedure implant, transcatheter valve, valve procedure, underwent valve, transcatheter
18
reports
Patient Registry: Valve Replacement After 5 Years
patient registry, registry, registry registry, registry patient, valve underwent
11
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
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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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