The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.The reported patient effects of thrombosis and stroke are listed in the rx acculink instructions for use (ifu) as a known potential patient effect associated with the use of a stent in carotid arteries.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The prolonged hospitalization was related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xact 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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