Citation: byung moon kim, yong sam shin, min woo baik, et al."pipeline embolization device for large/giant or fusiform aneurysms: an initial multi-center experience in korea." neurointervention 2016;11:10-17 http://dx.Doi.Org/10.5469/neuroint.2016.11.1.10.The device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patient post procedure and its cause was unknown.Information received from the same report as mfr: 2029214-2016-00483.
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Medtronic received information through literature review that there the following events occurred; transient occlusion of a jailed branch (n=3), and in-stent thrombosis (n=2) which caused side branch occlusion but completely resolved with intraaterial glycoprotein iib/iiia inhibitor infusion.Additionally, 19 patients presented with mass effect, 16 improved but three showed no changes in their presenting symptoms.Another case showed sluggish flow into the middle cerebral artery (mca) branch but was not treated, the patient had a sub-clinical infarction in the (mca territory).Another patient had an anterior thalamoperforator infarction due to the retained delivery wire of pipeline in the posterior communication artery.The article concluded that all patients had excellent outcomes (mrs, 0 or 1) during the follow-up period (median, 6 months; range, 2-30 months).Vascular imaging follow-up (n=31, 65.9%; median, 3 months, range, 1-25 months) showed complete or near occlusion of the aneurysm in 24 patients (77.4%) and decreased sac size in seven patients.The mean age of the patients within this group was, (58 years) and (m:f=10:35).
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