Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2014
Total Reports
1,341
Reports (30d)
13
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Serious Injury Cardiac Perforation EventsEmerging
events, injury, data, sapien ultra, thv
2
reports
Valve-in-Valve Procedure for Stenosis
ultra, clinical specialist, valve valve, field, field clinical
9
reports
Valve Stenosis 9 Years Post-Implant
clinical specialist, valve valve, approximately years, field, field clinical
8
reports
Complete AV Block Post-Implant
transfemoral, sapien ultra, resilia valve, ultra resilia, block
1
reports
Literature Batch: TAVR Clinical Outcomes
devices, evolut, patients, study, included
1
reports
Valve Explantation 3 Years Post-TAVR
registry, transfemoral, approximately years, procedure sapien, tavr procedure
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Incidence, Predictors, and Outcome of Paravalvular Leak after Transcatheter Aortic Valve Implantation
Abdullah Hagar, et al. · Journal of Interventional Cardiology · 2020
Deformation of Transcatheter Aortic Valve Prostheses: Implications for Hypoattenuating Leaflet Thickening and Clinical Outcomes
Miho Fukui, et al. · Circulation · 2022
Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study
Won‐Keun Kim, et al. · EuroIntervention · 2023
Clinical Comparison of a Novel Balloon-Expandable Versus a Self-Expanding Transcatheter Heart Valve for the Treatment of Patients with Severe Aortic Valve Stenosis: The EVAL Registry
Monica Barki, et al. · Journal of Clinical Medicine · 2022
Outcomes of transcatheter aortic valve replacement for pure native aortic regurgitation with the use of newer- vs. early-generation devices
Wei‐Hsian Yin, et al. · Annals of Translational Medicine · 2022
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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