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.Na.
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It was reported that the procedure was performed to treat a lesion in the moderately calcified, mildly tortuous internal carotid artery.A 40x8-6 xact self-expanding stent system (sess) was used along with an emboshield nav6.Six hours after the stent was implanted, the patient experienced a stroke, and thrombus was noted, which required aspiration.The patient is fine.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
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