HANCOCK II Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1999 · 10 device variants grouped
Total Reports
276
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Valve Explanted During Implant Procedure
adverse, medtronic received, effects, explanted replaced, valve explanted
5
reports
Permanent Pacemaker for Complete Heart Block
pacemaker, pacemaker implanted, implanted reason, permanent, permanent pacemaker
2
reports
Post-Implant Evaluation for Valve Replacement
reason evaluation, adverse, medtronic received, effects, post implant
2
reports
Evaluation for Transcatheter Replacement Post-Implant
patient evaluated, evaluation reported, replacement reason, reported years, evaluated transcatheter
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
Evidence
Related research
Urgent transapical mitral valve-in-valve implantation for acute leaflet disruption of a degenerated mitral bioprosthesis
Grzegorz Jodłowski, et al. · Kardiologia Polska · 2026
Successful Reversal of Late, Severe Thrombotic Bioprosthetic Mitral Valve Stenosis With Anticoagulation Therapy
J. Ignasi Galtés, et al. · Cureus · 2024
Transcatheter aortic valve-in-valve implantation for failed surgical bioprostheses: results from Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry
Zenon Huczek, et al. · Polskie Archiwum Medycyny Wewnętrznej · 2021
Effects of different valve-in-valve positions on the hydrodynamic properties of transcatheter aortic valves
Hong Fang, et al. · Computers in Biology and Medicine · 2025
Citations indexed from PubMed.
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