A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies stent thrombosis, aphasia, and hemiplegia as a potential complication associated with use of the device.
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It was reported that after implantation of a fred stent to treat an aneurysm of the left superior hypophyseal artery, the patient demonstrated sudden onset of aphasia and severe right arm and leg weakness.A ct showed no hemorrhage and cta showed an acute left internal carotid artery occlusion.The patient was taken for an emergent mechanical thrombectomy, which was successful.The patient's symptoms resolved shortly thereafter and they were prescribed ticagrelor 90mg twice per day.The patient remains neurologically intact five months after the procedure.
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