It was reported that on (b)(6) 2012, an acculink stent was successfully implanted in the left internal carotid artery.The patient was discharged home on (b)(6) 2012.On (b)(6) 2014, the patient expressed experiencing memory loss.Per computed tomography (ct), the right internal carotid had 44% stenosis and the left internal carotid, at the bifurcation, had 60% stenosis.Per study physician, the stenosis was not serious.There was no hospitalization, no treatment, and no intervention for the stenosis.There was no additional information provided.
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The reported patient effects of neurological deficit/dysfunction and stenosis are known observed and potential patient effects as listed in the rx acculink, domestic, instructions for use (ifu).Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacturing, design or labeling.Based on the information reviewed, there is no indication of a product deficiency.
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