Portico Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Transcatheter Aortic Valve (TAVR) · First cleared Sep 2021 · 4 device variants grouped
Total Reports
512
Reports (30d)
4
Active Signals
1
Open Recalls
5
What the reports describe · Claripulse analysis
Most commonly reported problems
Literature Batch: Self-Expanding Valve Outcomes
devices, evolut, patients, study, included
12
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
Procedural Safety and Device Performance of the Portico™ Valve from Experienced TAVI Centers: 30-Day Outcomes in the Multicenter CONFIDENCE Registry
Helge Möllmann, et al. · Journal of Clinical Medicine · 2022
Long-term outcomes following transcatheter aortic valve implantation with the Portico self-expanding valve
Arturo Giordano, et al. · Clinical Research in Cardiology · 2023
Outcomes of Transcatheter Aortic Valve Implantation with Abbott's Portico Compared to Edwards' SAPIEN 3: A Systematic Review and Meta-Analysis.
Gozdek M, et al. · Journal of clinical medicine · 2026
Transcatheter Aortic Valve Implantation with the Portico Valve: 2-Year Outcomes of a Multicenter, Real-World Registry
Matthaios Didagelos, et al. · Life · 2023
Thirty-day and one-year outcomes of the Navitor transcatheter heart valve in patients with aortic stenosis: the prospective, multicentre, global PORTICO NG Study
Lars Søndergaard, et al. · EuroIntervention · 2023
Citations indexed from PubMed.
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