The pipeline device will not be returned for evaluation as it was implanted in the patient.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: 2029214-2017-00258, 2029214-2017-00259.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information from literature that a patient experienced intraprocedural thrombus during placement of a pipeline device.The article states that the patient was undergoing treatment for a posterior inferior cerebellar artery (pica).The aneurysm size was 7mm.The aneurysm was 10mm in size.There were no device issues noted during implantation.The article states that the patient experienced distal embolization to a branch of the middle cerebral artery (mca) during pipeline placement.Abciximab (15mg) was administered and the clot resolved completely.Post-procedure, the patient experienced mild aphasia, which resolved within 24 hours without permanent deficits.On follow-up, all patients reviewed in this article had a glasgow outcome scale of 5.Deutschmann, h.A.Et al.(2011).Long-term follow-up after treatment of intracranial aneurysms with the pipeline embolization device: results from a single center.American journal of neuroradiology, 33(3), 481-486.Doi:10.3174/ajnr.A2790.
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