Citation: rizzoli g et al.Fifteen-year results with the hancock ii valve: a multicenter experience.J thorac cardiovasc surg.2006 sep;132(3):602-9, 609.E1-4.Doi:10.1016/j.Jtcvs.2006.05.03.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.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Medtronic received information via literature regarding 15-year outcome of patients who received an aortic or mitral valve replacement with a medtronic hancock ii bioprosthesis.All data were collected from multiple centers between 1983 through 2002.The study population included 1,274 patients; aortic bioprosthetic valves were implanted in 809 patients (predominantly male; mean age 68.4 years), and mitral bioprosthetic valves in 484 patients (predominantly female; mean age 65.8 years).No serial numbers were provided.Among all patients, 194 valve-related deaths occurred, 112 of which were aortic patients and 82 of which were mitral patients.Valve-related death was defined as ¿death caused by structural valvular deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, operated valvular endocarditis, or death related to reoperation of an operated valve.Sudden, unexplained, unexpected deaths of patients with an operated valve are included as valve related mortality.¿ no further details were provided regarding these death events.Among all patients, adverse events included: embolism, thrombosis, occlusion of the left coronary ostium, hemorrhage, endocarditis, dehiscence, aortic aneurysm/pseudoaneurysm with reoperation, and structural valve dysfunction (svd) which was defined as stenosis and/or incompetence.No additional adverse patient effects or product performance issues relating to the bioprostheses were reported.
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