Citation: murphy, e.Md et atl.The expanding role of endoscopic robotics in mitral valve surgery: 1,257 consecutive procedures.The society of thoracic surgeons.(2015).Nov;100(5):1675-81 doi 10.1016/j.Athoracsur.2015.05.068 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 the use of endoscopic robotics during the implant of a mitral valve annuloplasty ring or band.All data were collected from a single center between 2006 and 2013.The study population included 1,257 patients, some of which were implanted with a simulus annuloplasty ring/band.Serial numbers were not provided.The study population was predominantly male; mean age 59.3 ± 20.5 years of age.Among all patients adverse events included: conversion to sternotomy, bleeding, dissection, ring/band dehiscence, reoperation, stroke, infection, mild to moderate mitral regurgitation, atrial fibrillation, mitral stenosis, recurrent prolapse, endocarditis, thrombus and systolic anterior movement.Based on the available information, these events may have been attributed to a medtronic product.No additional adverse patient effects or product performance issues were reported.
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