Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015
Total Reports
2,493
Reports (30d)
47
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Aortic Death Events Post-ImplantEmerging
events, data, sapien ultra, thv, death
6
reports
Serious Injury Cardiac Perforation EventsEmerging
events, injury, data, sapien ultra, thv
6
reports
Delivery System Failure During Procedure
ultra, sheath, delivery, esheath, balloon
76
reports
Complete AV Block Post-Implant
transfemoral, sapien ultra, resilia valve, ultra resilia, block
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
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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