Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
779
Reports (30d)
2
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Patient Registry: Valve Explant After 7 Years
patient registry, registry, registry registry, registry patient, explanted
3
reports
Adverse Effects Following Valve Explant
adverse, medtronic received, reported medtronic, effects, additional adverse
1
reports
Patient Registry: Valve Replacement After 5 Years
patient registry, registry, registry registry, registry patient, valve underwent
1
reports
Transcatheter Valve-In-Valve Procedure After 17 Years
procedure implant, transcatheter valve, valve procedure, underwent valve, transcatheter
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Carpentier-Edwards Magna Ease bioprosthesis: a multicentre clinical experience and 12-year durability
Antonio Piperata, et al. · European Journal of Cardio-Thoracic Surgery · 2021
Bioprosthetic aortic valve diameter and thickness are directly related to leaflet fluttering: Results from a combined experimental and computational modeling study
Jae Ho Lee, et al. · JTCVS Open · 2020
Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement
Troels Højsgaard Jørgensen, et al. · European Heart Journal · 2021
Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis
Krzysztof Bartuś, et al. · European Journal of Cardio-Thoracic Surgery · 2020
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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