Citation: boe ba et al.Leaflet morphology classification of the melody transcatheter pulmonary valve.Congenit heart dis.2019 mar; 14(2):297-304.Doi: 10.1111/chd.12728.Epub 2018 dec 13.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.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information via literature regarding the leaflet morphology variations in the melody transcatheter pulmonary valve and an evaluation of the associated outcomes.All data were retrospectively collected from a single center between 2011 and 2016.The study¿s outcome analysis cohort included 55 patients and was predominantly male with a mean age of 22 years and a mean weight of 56 kg.All patients were implanted with medtronic melody transcatheter bioprosthetic valves in the pulmonary position.Of those, 2 were previously implanted with medtronic hancock valved conduits to repair the right ventricular outflow tract (rvot).No serial numbers were provided.Among all patients, one death occurred the day after the melody valve procedure in a patient with severe kyphoscoliosis and restrictive lung disease.It was reported that the patient developed respiratory arrest secondary to restrictive lung disease.The autopsy results showed severe hemorrhagic pulmonary edema and alveolar hemorrhage which likely lead to the respiratory failure.Based on the available information, medtronic product was not directly associated with the death.For both hancock patients, adverse events included: transcatheter valve-in-valve implantation due to pulmonary regurgitation, rvot obstruction, or a combination of both.Based on the available information, medtronic product was associated with the adverse events.Among all melody patients, adverse events included: surgical pulmonary valve replacement due to stenosis/unacceptable hemodynamic function and/or more than mild regurgitation (2 cases); transcatheter valve-in-valve implantation due to stent fracture (1 case); and surgical pulmonary valve replacement due to refractory ventricular arrhythmia (1 case).Based on the available information, medtronic product was associated with the adverse events.Among all melody patients, malfunctions included: stent fracture that did not require treatment or intervention (1 case).Based on the available information, medtronic product was associated with the malfunction.No additional adverse patient effects or product performance issues were reported.
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