ABBOTT (ST. JUDE MEDICAL) · Transcatheter Aortic Valve (TAVR) · First cleared Sep 2021 · 12 device variants grouped
Total Reports
3,003
Reports (30d)
148
Active Signals
10
Open Recalls
5
What the reports describe · Claripulse analysis
Transient Heart Block During Implant
selected implant, using, vision valve, flexnav, navitor
190
reports
Heart Block Reported via Registry
registry, data, navitor vision, vision valve, navitor
77
reports
Heart Block Post-Implant with FlexNav
non abbott, balloon, flexnav, flexnav delivery, abbott balloon
35
reports
New RBBB Post-Implant with FlexNav
balloon, vision valve, flexnav, navitor, flexnav delivery
32
reports
Literature Batch: TAVR Clinical Outcomes
devices, evolut, patients, study, included
31
reports
Cerebral Infarction on TAVR Day
sapien ultra, resilia valve, ultra resilia, valve replacement, tavi
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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
Transcatheter aortic valve implantation with Navitor Titan device: First Polish experience
Jarosław Trębacz, et al. · Kardiologia Polska · 2024
TAVR With the Novel Navitor Titan™ Transcatheter Heart Valve to Treat Aortic Stenosis Patients With Large Aortic Annuli
Vilhelmas Bajoras, et al. · Cardiovascular revascularization medicine · 2022
Predictors and Trends of New Permanent Pacemaker Implantation: A Subanalysis of the International Navitor IDE Study
Ibrahim Sultan, et al. · Structural Heart · 2024
Transcatheter Aortic Valve Replacement With the Navitor System: Real-World United Kingdom Experience
Apurva Bharucha, et al. · The American Journal of Cardiology · 2024
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
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 10 active signals detected right now.
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