Portico Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Transcatheter Aortic Valve (TAVR) · First cleared Sep 2021
Total Reports
328
Reports (30d)
2
Active Signals
1
Open Recalls
5
What the reports describe · Claripulse analysis
Most commonly reported problems
Literature Batch: TAVR Clinical Outcomes
evolut, patients, study, tavi, included
6
reports
Complete Heart Block Requiring Pacemaker
block, pacemaker, pacemaker implanted, complete, permanent pacemaker
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.
Keep exploring
Related devices in Structural
MitraClip
ABBOTT VASCULAR INC. · 18,209 reports
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC · 13,485 reports
Evolut FX
MEDTRONIC, INC. · 12,636 reports
Evolut PRO
MEDTRONIC, INC. · 7,566 reports
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC · 6,121 reports
CoreValve Evolut
MEDTRONIC, INC. · 4,371 reports
Want automated safety signal detection?
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.
Get Early AccessUnderstanding this data