ABBOTT (ST. JUDE MEDICAL) · Transcatheter Aortic Valve (TAVR) · First cleared Sep 2021
Total Reports
342
Reports (30d)
18
Active Signals
1
Open Recalls
5
What the reports describe · Claripulse analysis
Transient Heart Block During Implant
selected implant, using, vision valve, flexnav, navitor
36
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
Improved Transfemoral Accessibility and Positioning of the Portico Transcatheter Heart Valve With the New FlexNav Delivery System
Matteo Casenghi, et al. · Future Cardiology · 2021
Safety Profile of an Intra-Annular Self-Expanding Transcatheter Aortic Valve and Next-Generation Low-Profile Delivery System
Gregory P. Fontana, et al. · JACC: Cardiovascular Interventions · 2020
The Novel FlexNav Delivery System for Transcatheter Aortic Valve Implantation With the Portico Device: A Case Series
Nicola Corcione, et al. · The Journal of invasive cardiology/The journal of invasive cardiology · 2021
30-Day Outcomes With the Portico Transcatheter Heart Valve: Insights From a Multi-Centre Australian Observational Study
A. Camuglia, et al. · Heart Lung and Circulation · 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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