Citation: qureshi am, et al.O2479 - branch pulmonary artery valve implantation reduces pulmonary regurgitation and improves right v entricular size function in patients with large right ventricular outflow tracts.Cardiology in the young ¿ world congress of pediatric cardiology and cardiac surgery.July 16-21, 2017.27(supp.4):s52.Doi:10.1017/s104795111700110x.Published online: 12 july 2017.Earliest date of publish used for date of event.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 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 from a literature abstract regarding the outcomes following percutaneous branch pulmonary artery valve implantation in patients with large right ventricular outflow tracts.All data was retrospectively collected from ten centers.Of the 22 patients included in the study population, age 26 (13-58) years, weight 72 (26-147) kg, 18 were implanted with medtronic melody transcatheter pulmonary valves in the branch pulmonary artery.No unique device identifier numbers were provided.Among all patients, four late deaths occurred during follow-up (range of 1 month to 7.6 years).No statement was made suggesting a causal or contributory relationship between melody and the deaths.Among all patients, adverse events included: pulmonary emboli during the implant procedure; valve surgically explanted due to endocarditis at an undisclosed time after the implant procedure; and mild regurgitation through the implanted valve.Melody may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
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