Citation: cools b et al.Up to 11 years of experience with the melody valved stent in the right ventricular outflow tract.Eurointervention.2018 oct 12;14(9):e988-e994.Doi: 10.4244/eij-d-18-00054.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.
|
Medtronic received information via literature regarding the reported observations from 11 years of follow-up data after melody valve implantation in the pulmonary position.All data were collected from a single center between 2006 and 2017.The study population included 185 patients (predominantly male; mean age 19 years; mean weight 51.5 kg), all of which were implanted with a medtronic melody bioprosthetic valve (18, 20, and 22 mm prosthesis sizes were used), 23 were previously implanted with a medtronic contegra conduit, 1 was previously implanted with a medtronic hancock conduit, and 3 were previously implanted with a medtronic freestyle bioprosthetic valve.No serial numbers were provided.Among all patients, 3 deaths occurred.The physician/author noted that none of the deaths were related to the valve or the procedure.Based on the available information, medtronic product did not cause or contribute to these deaths.Among all contegra, hancock, and freestyle patients, adverse events included: pulmonary stenosis, pulmonary regurgitation, or a combination of both requiring percutaneous pulmonary valve implantation (melody valve placed inside degenerated bioprosthesis).Based on the available information, medtronic product may have caused or contributed to these adverse events.Among all melody patients, adverse events included: valve explant due to coronary compression (1 case), endocarditis (6 cases), and progressive sub-valvular pulmonary stenosis (1 case), redo percutaneous pulmonary valve implantation due to stenosis after endocarditis (3 cases) or conduit stenosis ¿valve wall thickening¿ 10 years after initial implant (1 case).Other adverse events included: moderate pulmonary regurgitation and increased gradients (unspecified number of cases).Based on the available information, medtronic product may have caused or contributed to these adverse events.Among all melody patients, device malfunctions included: type i stent fractures observed at a mean of 4.2 years after implant (14 cases).No interventions were reported as a consequence of these fractures.Additionally, a type iii stent fracture was observed 5 years after initial implant requiring redo percutaneous pulmonary valve implantation (1 case).Based on the available information, these malfunctions may have been attributed to medtronic product.No additional adverse patient effects or product performance issues were reported.
|