FlexNav Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Transcatheter Aortic Valve (TAVR) · First cleared Sep 2021
Total Reports
373
Reports (30d)
18
Active Signals
1
Open Recalls
5
What the reports describe · Claripulse analysis
Most commonly reported problems
Transient Heart Block During Valve Implant
selected implant, using, vision valve, flexnav, flexnav delivery
37
reports
Delivery System Misalignment with Heart Block
coronary cusp, balloon, vision valve, flexnav, flexnav delivery
1
reports
High Gradient Post-Implant with Heart Block
non abbott, balloon, flexnav, abbott balloon, flexnav delivery
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.
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