Zammar, s., buell, t., chen, c., crowley, r., ding, d., griessenauer, c.,.Simon, s.(2018).Outcomes after off-label use of the pipeline embolization device for intracranial aneurysms: a multicenter cohort study.World neurosurgery.Doi:10.1016/j.Wneu.2018.04.012 the pipeline device has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this article: 2029214-2018-00428 2029214-2018-00429, 2029214-2018-00430.If information is provided in the future, a supplemental report will be issued.
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Medtronic literature review found a report that post-procedure, pipeline migration was observed in one case.The article did not note any patient complications in association with this event.The purpose of this article was to examine the outcomes of the pipeline embolization device (ped) when used for 'off-label' indications.The authors identified 109 patients who underwent 'off-label' ped placement; reasons for off-label use were aneurysm size, location, or both.Of the 109 patients, 83.5% were female and 16.5% were male; the mean age was 54.4 years.
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