Citation: miranda wr et al.Prosthetic pulmonary valve and pulmonary conduit endocarditis: clinical, microbiological and echocardiographic features in adults.Eur heart j cardiovasc imaging.2016 aug;17(8):936-43.Doi: 10.1093/ehjci/jew086.Epub (b)(6) 2016.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.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information via literature regarding clinical and microbiological findings in adults with prosthetic pulmonary valve or right ventricle to pulmonary artery conduit infective endocarditis and to assess the yield of transthoracic and transesophageal echocardiography as diagnostic tools.All data were collected from a single center between 2000 and 2015.The study population included 17 patients (predominantly male; mean age 34 years), 2 of which were implanted with a 22 mm medtronic contegra conduit, 1 was implanted with a 29 mm medtronic hancock bioprothesis, 1 was implanted with a 31 mm medtronic hancock bioprosthesis, 1 was implanted with a 22 mm medtronic melody valve, and 1 was implanted with a 27 mm medtronic stentless valve (suspected to be a freestyle).Serial numbers not provided.Among all patients, 3 deaths occurred.Two were post-operative in-hospital deaths, 64 and 83 days respectively, due to bacteremia and fungal mediastinitis.One patient had an uncharacterized infection, underwent antibiotic therapy and had sudden death 24 days following diagnosis of infection.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients, adverse events included: endocarditis/infection, mild/moderate/severe regurgitation, elevated systolic gradients, cusp perforation, severe stenosis, moderate and severe obstruction, calcification, thickened and partially destroyed cusps, and valve replacement.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.No additional adverse patient effects or product performance issues were reported.
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