Navitor Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Transcatheter Aortic Valve (TAVR) · First cleared Sep 2021 · 12 device variants grouped
Total Reports
3,659
Reports (30d)
121
Active Signals
11
Open Recalls
5
What the reports describe · Claripulse analysis
Most commonly reported problems
Complete Heart Block During Procedure
block, pacemaker, left, coronary cusp, cusp
88
reports
Pre-BAV with Non-Abbott Balloon
bav performed, non abbott, pre, using, balloon
57
reports
Left Bundle Branch Block During Implant
left, coronary cusp, balloon, flexnav, flexnav delivery
46
reports
Third Degree AV Block with Pacemaker
block, navitor, pacemaker, site, cusp
30
reports
Literature Batch: Self-Expanding Valve Outcomes
devices, evolut, patients, study, included
26
reports
Severe Conduction Disturbance Requiring Pacemaker
pacemaker, did, registry, navitor vision, vision valve
22
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
A Comprehensive Evaluation of the NAVITOR Transcatheter Aortic Valve Replacement System.
Aoun J, et al. · Heart international · 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
Transcatheter aortic valve implantation with Navitor Titan device: First Polish experience
Jarosław Trębacz, et al. · Kardiologia Polska · 2024
30-Day and 1-Year Outcomes of Navitor Transcatheter Aortic Valve in Low- or Intermediate-Risk Patients
Stephen Grant Worthley, et al. · JACC: Cardiovascular Interventions · 2025
Transcatheter aortic valve-in-valve implantation for failed surgical aortic bioprostheses using the Navitor platform: early outcomes in a consecutive single-center cohort
Robert Sobczyński, et al. · Cardiology Journal · 2026
Citations indexed from PubMed.
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