Medtronic received information via literature regarding the risk factors for infective endocarditis in patients who underwent transcatheter pulmonary valve replacement (tpvr).All data were retrospectively collected from a single center between october 2010 and october 2017.The study population included 235 patients and was predominantly male with a mean age of 22 years and a mean weight of 63 kg.Of those, 183 were implanted with medtronic melody transcatheter valves; 3 were previously implanted with medtronic hancock valved conduits; and 2 were previously implanted with medtronic mosaic surgical valves.No serial numbers were provided.It was reported that the median duration from transcatheter valve implant to onset of endocarditis was 3.3 years (range 2 to 7.2 years).Among all melody patients, 2 deaths were reported.The causes of death were due to septic shock (1) and cardiac arrest secondary to heart failure 1.5 years after recurrent episode of endocarditis (1).Based on the available information, medtronic product was not directly associated with the deaths.Among all melody patients, adverse events included: severe pulmonary stenosis and/or stent fracture that required redo tpvr, bacterial endocarditis, surgical explant and replacement of the valve due to fungal endocarditis, valvular mobile mass and/or vegetations due to bacterial or fungal endocarditis, extracorporeal membrane oxygenation support, moderate-severe pulmonary regurgitation, and high peak/mean residual gradients.Based on the available information, medtronic product was associated with the adverse events.Among all hancock and mosaic patients, adverse events included: transcatheter valve-in-valve implantation.The reason for valve-in- valve implantation was not reported.Other adverse events observed: moderate-severe pulmonary regurgitation and high peak/mean gradients.Based on the available information, medtronic product was associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
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