Citation: y.Okamoto, "early and late outcomes of aortic valve replacement with aortic annular enlargement: a propensity analysis" thorac cardiovasc surg 2016;64:410¿417.Doi http://dx.Doi.Org/10.1055/s-0035-1563669.Issn 0171-6425.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).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information via literature regarding early and late outcomes of aortic valve replacement with aortic annular enlargement: a propensity analysis.All data were collected from a single center between january 2001 and july 2014.The study population included 589 patients (predominantly female, mean age 73 years), 51 of which were implanted with medtronic mosaic (serial numbers not provided).Among all patients 11 deaths occurred.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients adverse events included: complete heart block, low output syndrome, perioperative mi, stroke, ventricular fibrillation, sepsis, chest infection, and congestive heart failure.Based on the available information, these events may have been attributed to medtronic product.
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