Estimated date of event.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of thrombosis is listed in the xact instructions for use as a known potential patient effect potentially associated with carotid stents and embolic protection systems.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a heavily tortuous, mildly calcified left internal carotid artery.An xact stent was implanted on (b)(6) 2020.Three weeks later, in-stent thrombosis was noted via a follow up ultrasound.However, the patient had no symptoms.The patient confirmed they were still taking standard medications without interruptions.No further treatment was provided as the patient is doing well without issue.There was no adverse patient sequela or clinically significant delay.No additional information was provided.
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