Medtronic received information via literature regarding the outcomes of redo pulmonary valve replacement (pvr) for bioprosthetic pulmonary valve failure in patients with congenital heart disease all data were collected from a single center between november 1999 and june 2013.The study population included 61 patients predominantly male; mean age at initial pvr was 7.0 years and the median age at redo pvr was 13.5 years, 17 of the 61 were implanted with medtronic freestyle and 14 were implanted with a medtronic hancock ii (serial numbers not provided).Among all patients, adverse events included: redo operation due to pulmonary stenosis, pulmonary regurgitation and infective endocarditis resulting in high gradients.Also reported were stroke, myocardial infarction, renal failure, respiratory complications, sternotomy wound problems (infection and superficial dehiscence), bleeding and postoperative arrhythmia's.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and medtronic product.
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