The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.The reported patient effects of ischemia, thrombosis and stroke are listed in the xact instruction for use (ifu) as known adverse events potentially associated with carotid stents and embolic protection systems.Based on the information provided, a conclusive cause for the reported stent fracture and subsequent patient effects could not be determined.The unexpected medical intervention and hospitalization were related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The acculink stent referenced is filed under a separate medwatch report number.
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It was reported that on (b)(6) 2021, a 10tx40x136 xact carotid stent was implanted to treat an occlusion in the heavily calcified, mildly tortuous, 90% stenosed left vertebral artery.On (b)(6) 2021, the patient presented for a second planned procedure in another vessel; however, it was noted that the xact stent implanted in may was broken circumferentially and severely blocking the blood flow.A 7-10/40 acculink stent was implanted as treatment, relieving the patient symptoms.Post procedure, the patient experienced a cerebral infarction from thrombus and was hospitalized for observation.No additional information was provided.
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