Navitor Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Transcatheter Aortic Valve (TAVR) · First cleared Sep 2021 · 12 device variants grouped
Total Reports
3,538
Reports (30d)
133
Active Signals
0
Open Recalls
5
What the reports describe · Claripulse analysis
Most commonly reported problems
Death Following Tricuspid Surgery Post-ImplantEmerging
registry, implant sapien, sapien ultra, ultra resilia, ultra
1
reports
Successful Implant with No Complications
non abbott, vision valve, flexnav, flexnav delivery, navitor
235
reports
Literature Batch: Self-Expanding Valve Outcomes
evolut, patients, study, tavi, included
16
reports
Heart Block Requiring Pacemaker Post-Implant
pacemaker, did, registry, navitor vision, vision valve
13
reports
Balloon Rupture During Valve-in-Valve Procedure
ultra, clinical specialist, specialist, sapien ultra, resilia valve
2
reports
Transient Bradycardia During Pre-Implant BAV
dcs, non medtronic, tav, bioprosthetic, balloon
2
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
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
A Comprehensive Evaluation of the NAVITOR Transcatheter Aortic Valve Replacement System
Joe Aoun, et al. · Heart International · 2024
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 implantation with the novel‐generation Navitor device: Procedural and early outcomes
Nicola Corcione, et al. · Catheterization and Cardiovascular Interventions · 2022
Citations indexed from PubMed.
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