FlexNav Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Transcatheter Aortic Valve (TAVR) · First cleared Sep 2021 · 4 device variants grouped
Total Reports
697
Reports (30d)
26
Active Signals
2
Open Recalls
5
What the reports describe · Claripulse analysis
Most commonly reported problems
Recapture Failure During Valve Deployment
selected implant, using, navitor vision, vision valve, flexnav
14
reports
Resistance Encountered During Implant Attempt
selected implant, selected, flexnav, flexnav delivery, navitor
11
reports
Pre-BAV with Non-Abbott Balloon
bav performed, non abbott, pre, using, balloon
7
reports
Left Bundle Branch Block During Implant
left, coronary cusp, balloon, flexnav, flexnav delivery
2
reports
Complete Heart Block During Procedure
block, pacemaker, left, coronary cusp, cusp
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
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
Related research
One-Year Results of the Portico Transcatheter Aortic Heart Valve Using the Next-Generation FlexNav Delivery System
Gregory P. Fontana, et al. · Journal of the Society for Cardiovascular Angiography & Interventions · 2022
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
Real-Life Performance and Clinical Outcomes of Portico Transcatheter Aortic Valve with FlexNav Delivery System: One-Year Data from a Single-Center Experience
Abdullah Yıldırım, et al. · Journal of Clinical Medicine · 2023
Citations indexed from PubMed.
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