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.The reported patient effects of thrombosis and stroke (cerebrovascular accident) are listed in the x.Act carotid stent system instructions for use as possible adverse events associated with the use of this product.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.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 moderately calcified, mildly tortuous internal carotid.A 40x8-6 xact self-expanding stent system (sess) was used along with an emboshield nav6 successfully in the carotid procedure.However, 6 hours post stenting the patient had a stroke and thrombus was confirmed via angiograph.Thrombus aspiration was performed and patient fully recovered from the thrombus.Additionally, it was noted that the event did delay the patient's hospital stay.There was no adverse patient sequela and clinically significant delay was reported.No additional information was provided.
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