Citation: butany et al.A 10-year comparison of explanted hancock-ii and carpentier-edwards supraannular bioprostheses.Cardiovascular pathology, 2007 jan-feb; 16(1): 4-13.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information via literature regarding a 10-year comparison of explanted hancock-ii and carpentier-edwards supra-annular bioprostheses.All data were collected from bioprostheses explanted from a single center between january 1994 and june 2004.The overall implant population included 2839 patients, 2297 patients (predominantly male, mean age 62.8 years) of which were implanted with medtronic hancock ii bioprosthetic valves (no serial numbers provided) designed for atrial or mitral valve positions.From january 1994 and june 2004, a total of 163 valves (98 hancock ii and 65 carpentier-edwards) were explanted and analyzed in this study.Observations of explanted hancock ii valves included evidence of: outward splaying of the stent posts, material dehiscence/detachment, calcification, tear/perforation, cusp prolapse, pannus, thrombus, endocarditis, hemorrhage, lipid/serum insudation, stenosis, and incompetence.Based on the available information medtronic product was directly associated with the observations.No additional adverse patient effects or product performance issues were reported.
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