Citation: sinha s, et al.Application of transcatheter valves for aortic valve replacement in pediatric patients: a case series.Catheter cardiovasc interv.2019 oct 14.Doi: 10.1002/ccd.28505.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 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 transcatheter aortic valve replacement (tavr) in a pediatric population with congenital heart diseases.All data were retrospectively collected from a single center between january 2012 and january 2018.The study population included seven patients (mean age 10 years, mean weight 34.8 kg), two of which were implanted with a medtronic melody bioprosthetic valve (no serial numbers provided).Among all medtronic melody patients, adverse events included: mild paravalvular leak and leaflet avulsion resulting in moderate-severe aortic regurgitation and/or stenosis which required transcatheter valve replacement.Based on the available information medtronic product was directly associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
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