Medtronic received information via literature regarding a histological analysis of explanted contegra conduits that had been used for right ventricular outflow tract (rvot) reconstruction to attempt to identify the pathological mechanisms for graft failure.All data were collected from two centers between 2015 and 2018.The study population included 13 patients (predominantly male; mean age 11 years), all were previously implanted with medtronic contegra valved conduits (no serial numbers provided).It was noted that conduit explantation occurred at a mean 8.3 years after implant.Among all patients, adverse events included: conduit explantation due to stenosis, high gradients, pulmonary insufficiency (mean regurgitation grade ii), and aneurysm of rvot.Specific degenerative characteristics observed during detailed examination: conduit wall calcification, leaflet thickening or calcification, fibrosis, loss of elasticity, and decline in conduit/graft elastic fibers.Based on the available information, medtronic product was directly associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
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