Medtronic received information via literature regarding surgical therapy of infective endocarditis following interventional or surgical pulmonary valve replacement.All data were collected from a single center between march 2013 and july 2020.The study population included 20 patients (predominantly male, mean age 15.9 years, mean weigh 53.6 kg) all with congenital heart disease and a diagnosis of infective endocarditis.Sixteen of the twenty patients were implanted with a medtronic melody valve (n = 11) or contegra bovine jugular vein graft conduit (n = 5).No unique device identifier numbers were provided.Among all patients, adverse events included: infective endocarditis, thickening of valve leaflets, stenosis, severe right ventricular dysfunction, and pulmonary artery embolism.Time to infective endocarditis of melody valve or contegra conduits ranged from 6 months to 9.4 years.Based on the available information medtronic product may have been associated with the adverse event(s).Treatment for all patients included reoperation to resect all infected prosthetic material from the right ventricular outflow tract up to the pulmonary bifurcation and replace with pulmonary homografts.Surgical findings of the infected conduits included: infection of valve leaflets only, massive valve or conduit destruction, and/or vegetation extended to other areas beyond the prosthetic.Post procedurally, six patients underwent additional procedures to address other issues.During follow-up, with a median of 205.5 days, there were no deaths and no cases of recurrent endocarditis.No additional adverse patient effects or product performance issues were reported.
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