Citation: chalouhi et al.Flow diversion versus traditional aneurysm embolization strategies: analysis of fluoroscopy and procedure times.J neurointervent surg 2014;6;291-295.Covidien received information through literature review that six patients experienced intraoperative events during pipeline embolization device (ped) placement to treat aneurysms.It was reported that intraoperative events occurred in 6 patients: internal carotid artery dissection in two and stent deployment complications in four patients."the purpose of this study was to compare the pipeline embolization device (ped) and traditional embolization strategies in terms of fluoroscopy and procedure time.Fluoroscopy and procedure times (in minutes) were retrospectively analyzed and compared between 127 patients treated with the ped, 86 patients treated with single stage stent assisted coiling (sac), and 16 patients treated with onyx hd 500 at thomas jefferson university hospital." additional information regarding the ped treatment group: "a total of 127 patients, including 102 women and 25 men ranging in age from 17 to 88 years (mean 56 years), were treated with the ped.Mean aneurysm size was 10 mm.Most treated aneurysms were located in the anterior circulation.Three patients (2.4%) were treated in the setting of subarachnoid hemorrhage.The number of peds used was 1.37 per patient.
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Article website: http://jnis.Bmj.Com/content/6/4/291.Long.There was no additional information regarding the outcome of the six intraoperative events.The lot history record review was not possible since the lot numbers were not reported.The devices will not be returned for analysis as they were implanted in the patient; therefore, the event cause could not be determined.There was limited information about the device and/or the patient, therefore all serious adverse events were captured in this report.(b)(4).
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