Citation: authors - brian h.Morray; doff b.Mcelhinney; younes boudjemline; marc gewillig; dennis w.Kim; elena k.Grant; martin l.Bocks; mary h.Martin\ journal name: circ cardiovasc interv.Title: multicenter experience evaluating transcatheter pulmonary valve replacement in bovine jugular vein (contegra) right ventricle to pulmonary artery conduits year and issue: 2017; 10(6) reference #: 10.1161/circinterventions.116.004914 the earliest date of publication was used for the event date for this literature article.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 the return of the product or serial numbers, no definitive conclusion can be made regarding the clinical observations.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 the study of short and intermediate-term outcomes of medtronic melody transcatheter pulmonary valve replacement (tpvr) within the medtronic contegra conduit in the right ventricle to pulmonary artery position.All data was collected retrospective from multiple centers.The study population included 136 patients predominantly male, mean age 14.5 years old, mean weight of 53 kg.The serial numbers for these patients was not provided.Among all patients adverse events included: stent fractures, endocarditis, coronary artery compression, conduit stenosis, conduit re gurgitation, conduit calcification, conduit increased gradient, femoral arteriovenous fistula, conduit tear, conduit obstruction, and rvot obstruction.Based on the available information, these events may have been attributed to a medtronic product.No additional adverse patient effects or product performance issues were reported.
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