HANCOCK II ULTRA Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1999 · 5 device variants grouped
Total Reports
108
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Evaluation for Transcatheter Replacement Post-Implant
patient evaluated, evaluation reported, replacement reason, reported years, evaluated transcatheter
3
reports
Post-Implant Evaluation for Valve Replacement
reason evaluation, adverse, medtronic received, effects, post implant
2
reports
Valve Explanted During Implant Procedure
adverse, medtronic received, effects, explanted replaced, valve explanted
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Pericardial Versus Porcine Valves for Surgical Aortic Valve Replacement.
Shin HJ, et al. · Korean circulation journal · 2021
Valve-in-valve transcatheter transfemoral mitral valve implantation (ViV-TMVI): Characteristics and early results from a nationwide registry
Zenon Huczek, et al. · Kardiologia Polska · 2023
In Vitro Calcification of Bioprosthetic Heart Valves: Method Validation by Comparative Heart Valve Calcification Testing.
Kiesendahl N, et al. · Artificial organs · 2025
Comparison of TAVR and SAVR in elderly patients with pure native aortic regurgitation: outcomes and midterm results.
Zhao C, et al. · Cardiovascular diagnosis and therapy · 2025
Citations indexed from PubMed.
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