(b)(4).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.Based on the similar incident review, there is no indication of a lot specific product quality issue.The reported patient effect of hypotension is listed in the xact carotid stent systems instructions for use as a known patient effect of the stenting procedure.The investigation was unable to determine a conclusive cause for the reported difficult to deploy and hypotension.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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It was reported that the patient underwent a carotid procedure on (b)(6) 2018, treating a target lesion in the lightly calcified right common carotid artery.The 9.0 x 30 mm xact stent was deployed, but a delay was encountered while attempting to separate the stent from the delivery system.Eventually, the stent fully deployed in the lesion and the delivery system successfully removed; however, during the delay, the patient experienced severe hypotension, which was treated with neosynephrine.The physician felt the delay was clinically significant.The patient condition resolved.No additional information was provided.
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