Medtronic received information via literature regarding patients with tetralogy of fallot (tof), pulmonary atresia (pa), and other congenital right ventricular outflow tract (rvot) malformations, using polytetrafluoroethylene (ptfe) monocusp outflow tract patches (motp) to relieve obstruction and provide pulmonary valve competence.All data were collected from a single center between 1994-2014.The study population included 171 patients (predominantly female, mean age 1.5 years), 21 of which were implanted with medtronic contegra, 5 were implanted with a medtronic freestyle, 4 were implanted with a medtronic melody and 2 were implanted with a medtronic mosaic (serial numbers not provided).Among all patients' adverse events included: arrhythmias, low cardiac output, bowel ischemia, pleural effusion, reoperation, moderate or severe tricuspid regurgitation, severe pulmonary stenosis or severe pulmonary regurgitation, dilated right ventricle (rv), rv dysfunction and failure, pulmonary stenosis, endocarditis, residual ventricular septal defect (vsd), pseudoaneurysm, supravalvular or subvalvular stenosis, outgrowth and complete heart block (chb) with permanent pacemaker implant.Based on the available information, these events may have been attributed to medtronic product.No additional adverse patient effects or product performance issues were reported.
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