It was reported that the procedure was to treat a de novo lesion located in the very narrow, heavily calcified and highly tortuous distal internal carotid artery.Due to the anatomy, it took a long time to get the acculink rx 9/40 stent delivery system (sds) to the lesion; however, it was able to cross, but barely.An attempt was made to deploy the stent; however, it would not deploy due the difficulty with the sds handle.Several more attempts were made to deploy the stent; however, these failed so the acculink sds was retracted from the patient.A new accculink rx 9/40 was used, was able to enter through the sheath smoothly and was deployed successfully.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.Returned device analysis revealed a tear in the shaft of the delivery system.
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(b)(4).Evaluation summary: the device was returned for analysis.The difficulty deploying the stent was not able to be confirmed.The reported resistance could not be confirmed as it was based on case circumstances.The inner member was torn 2 cm distal to the guide wire exit notch for a length of 1 mm.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 of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.
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