The pipeline devices will not be returned for evaluation as they remain implanted in the patients.Based on the provided information, there does not appear to have been any defect of the devices during use.The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2019-00723.If information is provided in the future, a supplemental report will be issued.
|
Bender, m., vo, c., jiang, b., campos, j., zarrin, d., xu, r., coon, a.(2018).Pipeline embolization for salvage treatment of previously stented residual and recurrent cerebral aneurysms.Interventional neurology, 7 (6), 359-369.Doi: 10.1159/000489018.Medtronic literature review found reports of complications during or after pipeline placement.The purpose of this article was to assess the safety and effectiveness of the pipeline for persistent and recurrent aneurysms previously treated.The authors reviewed the results of 18 patients, average age was 57 years and 80% were female.All 18 patients had undergone initial treatment, experienced aneurysm recurrence, then underwent retreatment in which pipeline (ped) devices were placed.Of the 18 patients, 13 patients had been undergone ped implantation as initial treatment.The ped was noted to have foreshortened in two cases.The article notes the following complications, which occurred during the retreatment procedure: 2 patients experienced vasospasm and underwent verapamil infusion.2 patients experienced ped thrombosis.
|