Medtronic received information via literature regarding the outcomes after transcatheter pulmonary valve implantation (tpvi) using the melody valve in patients with congenital heart disease.All data were retrospectively collected from 42 centers between december 2006 and september 2013.The study population included 845 patients and was predominantly male with a mean age of 21 years and a mean weight of 59 kg.All were implanted with medtronic melody transcatheter pulmonary valves.No serial numbers were provided.Among all patients, 13 deaths were reported.The causes of death were due to tpvi endocarditis (9), coronary artery compression (3), and bleeding after conduit rupture (1).Based on the available information, medtronic product was associated with these deaths.Among all patients, adverse events included: reoperation and valve explantation due to endocarditis, stenosis, stent fractures, or chronic pericardial effusion; balloon dilation of the melody valve or valve-in-valve reintervention due to pulmonary restenosis, stent fractures, or endocarditis; coronary artery compression that required surgical treatment; bleeding due to conduit rupture that required interventional treatment; bleeding due to pulmonary artery injury that required interventional or surgical treatment; valve dislodgement; obstruction of pulmonary artery branches that required interventional treatment; arrhythmia; dislocation of pacemaker/implantable cardioverter defibrillator leads; injury of a right ventricular papillary muscle; pulmonary embolism; pulmonary edema; balloon rupture that required interventional treatment; and vascular access complications that required interventional or surgical treatment.Based on the available information, medtronic product was associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
|