ABBOTT (ST. JUDE MEDICAL) · Transcatheter Aortic Valve (TAVR) · First cleared Sep 2021
Total Reports
322
Reports (30d)
1
Active Signals
1
Open Recalls
5
What the reports describe · Claripulse analysis
Literature Batch: TAVR Clinical Outcomes
devices, evolut, patients, study, included
12
reports
Heart Block Reported via Registry
registry, data, navitor vision, vision valve, navitor
1
reports
Structural Valve Deterioration After 2.5 Years
tav, bioprosthetic, implant transcatheter, bioprosthetic valve, years
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Oct 17, 2024 · Open, Classified
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Oct 17, 2024 · Open, Classified
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Oct 17, 2024 · Open, Classified
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Oct 17, 2024 · Open, Classified
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Oct 17, 2024 · Open, Classified
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
Evidence
Long-term outcomes following transcatheter aortic valve implantation with the Portico self-expanding valve
Arturo Giordano, et al. · Clinical Research in Cardiology · 2023
One-Year Results of the Portico Transcatheter Aortic Heart Valve Using the Next-Generation FlexNav Delivery System.
Fontana GP, et al. · 2022
Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry.
Mollmann H, et al. · 2022
Real-Life Performance and Clinical Outcomes of Portico Transcatheter Aortic Valve with FlexNav Delivery System: One-Year Data from a Single-Center Experience.
Yildirim A, et al. · 2023
In-hospital outcomes of Portico transcatheter aortic valve replacement with the FlexNav as compared to the first-generation delivery system.
Rigattieri S, et al. · 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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