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 and carotid stent delivery system was returned for analysis.Upon initial investigation, the distal tip of the pusher appeared to have been damaged, and the platinum marker detached stainless steel coils are not present at the distal tip of the pusher.The distal marker band to the distal tip of the pusher was measured to see how much was detached; approximately 17mm remained, thus meaning that approximately 20mm of the pusher was detached.Based on the available information and investigation, the reported complaint is confirmed; the failure mode of the pusher was consistent with a kink overload resulting in the fracture.The broken end was severely bent backwards upon itself and twisted, which is consistent with it being kinked.The root cause of this complaint is due to the wire being twisted into a kink and then pulled away causing a shear/tensile overload.
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It was reported that during treatment of a left-side, posterior communicating aneurysm, the tip of the delivery wire of the lvis jr stent detached in the internal carotid artery at the neck of the blister aneurysm.This was noticed after the remainder of the lvis stent was re-sheathed and removed from the body.Another lvis jr.Stent was then placed to secure the detached segment of the stent to the wall of the vessel.There was no reported injury and the patient was noted to be in fair condition post-procedure.
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