Citation: chatterjee, a.Md et al.Transcatheter pulmonary valve implantation: a comprehensive systematic review and meta-analyses of observational studies.Journal of the american heart association.(2017) aug 4;6(8).Pii: e006432 doi 10.1161/jaha.117.006432.Earliest date of e-publish/publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Medtronic received information via literature review regarding outcomes of transcatheter pulmonary valve implantation.All data were collected from a meta-analysis review that included articles written before august 31, 2016.Nineteen articles were identified that included 1044 patients, which were implanted with either a melody transcatheter pulmonary valve or a non-medtronic valve.Serial numbers were not provided.Among all patients, deaths were attributed to sepsis/endocarditis, coronary compression or dissection.Based on the available information, these events may have been attributed to a medtronic product.However as multiple manufacturers were noted in the literature, a direct correlation could not be made between the observed adverse events and the medtronic product.No additional adverse patient effects or product performance issues were reported.
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