Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015
Total Reports
13,096
Reports (30d)
284
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Serious Injury Events Outside GuidelinesEmerging
events, sapien ultra, thv, resilia, ultra resilia
28
reports
Serious Injury Cardiac Perforation EventsEmerging
events, injury, data, sapien ultra, thv
25
reports
Aortic Death Events Post-ImplantEmerging
events, data, sapien ultra, thv, death
23
reports
Delivery System Failure During Procedure
ultra, sheath, delivery, esheath, balloon
109
reports
Valve Stenosis 9 Years Post-Implant
clinical specialist, valve valve, approximately years, field, field clinical
94
reports
Valve-in-Valve Procedure for Stenosis
ultra, clinical specialist, valve valve, field, field clinical
69
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Intermediate Follow-Up of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation in Patients With Small Aortic Annuli
Wassim Mosleh, et al. · The American Journal of Cardiology · 2023
Outcomes of transcatheter aortic valve replacement in patients with cardiogenic shock
Kashish Goel, et al. · European Heart Journal · 2023
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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