Portico Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Transcatheter Aortic Valve (TAVR) · First cleared Sep 2021
Total Reports
338
Reports (30d)
0
Active Signals
0
Open Recalls
5
What the reports describe · Claripulse analysis
Most commonly reported problems
Literature Batch: Self-Expanding Valve Outcomes
evolut, patients, study, tavi, included
11
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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
Long-term outcomes following transcatheter aortic valve implantation with the Portico self-expanding valve
Arturo Giordano, et al. · Clinical Research in Cardiology · 2023
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
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. · PubMed · 2023
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
Short‐Term Outcomes Following Transcatheter Valve‐in‐Valve Implantation With Portico or Navitor Valves: The Barts Heart Center Experience
Vincenzo Tufaro, et al. · Catheterization and Cardiovascular Interventions · 2025
Citations indexed from PubMed.
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