It was reported that the procedure was to treat an eccentric lesion in the distal internal carotid artery with heavy tortuosity.The 6-8/40 acculink delivery system was advanced with some resistance noted.The difficulty was noted due to the highly tortuous vessel, and it took a long time.Finally, some force was used and the acculink passed the lesion, but when an attempt was made to deploy the stent, the stent did not deploy.Several attempts were made, but the stent did not deploy.The acculink delivery system was removed, and it was noted that 3 or 4 cells of stent struts were exposed.A new device was used to continue 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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(b)(4).Evaluation summary: the device was returned for analysis.The difficulty deploying the stent and partial deployment was able to be confirmed.The reported resistance could not be confirmed as it was based on case circumstances.Based on a visual, dimensional, and functional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query/review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the reviewed information, no product deficiency was identified.
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