Citation: virk sa et al.Percutaneous pulmonary valve implantation: a systematic review of clinical outcomes.Int j cardiol.2015 dec 15;201:487-9.Doi: 10.1016/j.Ijcard.2015.08.119.Epub 2015 aug 18.Earliest date of publish used for event date and death 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 an assessment of the clinical outcomes in patients with right ventricular outflow tract (rvot) dysfunction who underwent percutaneous pulmonary valve implantation (ppvi).All data were collected from a meta-analysis systematic review of twelve studies between 2008 and 2014.The study population included 677 patients and was predominantly male with a mean age of 21 years.Of those, 602 were implanted with medtronic melody transcatheter pulmonary valves.No serial numbers were provided.Among all patients, 5 deaths were reported.Of those, an unidentified number may have been due to endocarditis (earliest case occurred at 1.9 months after ppvi).Based on the available information, medtronic product may have been associated with the deaths.Among all patients, adverse events included: conversion to surgery; conduit rupture; endocarditis (earliest case occurred at 1.9 months after ppvi); valve explant due to endocarditis; valve embolization; pulmonary artery obstruction; coronary artery compression; and restenosis and rvot reintervention due to stent fractures.Based on the available information, medtronic product was associated with the adverse events.Among all patients, malfunctions included: stent fractures that did not require intervention.Based on the available information, medtronic product was associated with the malfunctions.No additional adverse patient effects or product performance issues were reported.
|