The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The pusher was returned for evaluation; the implant coil was not returned.The distal black pet on the heater coil section was noted to be burned.There were several kinks on the pusher.The attachment section had a secure tie-knot.The pusher was dissected to expose the attachment tether to determine the type of detachment.The attachment tether tip demonstrated a mushroom and a rebound length of (b)(6),' which is indicative of a thermal detachment.Based on the available information and evaluation of the returned device, the complaint cannot be verified as the implant coil segment was missing.However, the pusher exhibited evidence of a normal thermal detachment.The investigation was limited by not having the coil section of the implant to analyze.The instructions for use (ifu) identifies thrombus as a potential complication associated with use of the device.
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It was reported that during the placement of the last embolization coil in a giant saccular aneurysm, the coil "moved" partially inside the stent.During a withdrawal attempt, the coil detached partially inside the stent.Thrombus was noted inside the stent, which was treated successfully with aggrastat.The patient's current status is reported to be stable.
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