Citation: eicken, a.Md.Percutaneous pulmonary valve implantation (ppvi): indications and outcome (2014).Year of presentation was 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 a presentation on percutaneous pulmonary valve implantation.All data were collected from a single center, registry and a medtronic sponsored clinical study.Patient were implanted with a medtronic melody transcatheter pulmonary valve and a non-medtronic transcatheter pulmonary valve.Serial numbers were not provided.The study population was predominantly male; mean age 18.9 years; mean weight 60.8 kg.Among all patients adverse events included: balloon aortic valvuloplasty (bav) that resulted in grade 2-3 stent fractures, valve-in-valve, trivial to severe pulmonary regurgitation with subsequent increased gradient measurements, coronary artery occlusion, right ventricular outflow tract (rvot) aneurysm treated with stent placement, pulmonary artery perforation and valve replacement.No additional adverse patient effects or product performance issues were reported.
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