The device has not been returned for evaluation; product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that during embolization treatment, the pushwire proximal tip broken during removing of the pushwire after pipeline implanted.The patient underwent embolization treatment of unruptured saccular aneurysm located in internal carotid artery.It was reported that pipeline deployed per the ifu, microcatheter re-advanced post deployment of pipelined and pushwire recaptured.15mm tip wire broke off while removing and remained in the proximal catheter.No patient injury was reported.
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The device was returned for evaluation and the clinical observation was confirmed.As received, the pushwire was found separated into two segments.The distal broken segment was found stuck inside distal segment of the microcatheter.The proximal segment of the pushwire was found outside of the catheter.During evaluation, the catheter was then cut to remove the distal broken segment of the pipeline flex pushwire.The pipeline flex braid was not returned as it was implanted in the patient.Additionally, the pushwire found bent at the proximal end.The broken end of the pipeline flex pushwire was then sent out for scanning electron microscopy (sem) analysis.Based on the analysis findings, the event description and the sem analysis; the failure mode for the ¿pushwire separation¿ is tensile overload.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.All products are 100% inspected for damage and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
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