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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulty.It may be possible that the distal sheath was restricted or entrapped within the anatomy causing the stent to "jump" during deployment due to built-up tension within the shaft lumens of the delivery system resulting in a spring like release of the stent; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a heavily calcified, moderately tortuous, 85% stenosed lesion in the carotid artery.A 014 acculink carotid stent was advanced to the target lesion but during deployment, the stent jumped and missed the target lesion.An 8x30mm acculink stent was used to cover the target lesion and successfully completed the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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