Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015
Total Reports
348
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Delivery System Failure During Procedure
ultra, sheath, delivery, esheath, balloon
1
reports
Valve Explantation 4 Years Post-Implant
valve aortic, aortic position, registry, months, ultra
1
reports
Valve-in-Valve Procedure for Stenosis
ultra, clinical specialist, valve valve, field, field clinical
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve: the S3U registry.
Saia F, et al. · 2020
One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry.
Cannata S, et al. · EuroIntervention · 2023
Routine post-dilatation at nominal volume to optimise the expansion of balloon-expandable valves: the DOUBLE-TAP study
Ali Husain, et al. · EuroIntervention · 2025
Peripheral intravascular lithotripsy for transcatheter aortic valve implantation: a multicentre observational study
Giulia Nardi, et al. · EuroIntervention · 2022
Feasibility of redo-TAVI in self-expanding Evolut valves: a CT analysis from the Evolut Low Risk Trial substudy
Kendra J. Grubb, et al. · EuroIntervention · 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. 1 active signal detected right now.
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