It was reported through a research article identifying emboshield nav6, accunet, and acculink devices that may be related to the following: death, stroke.Specific patient information is documented as unknown.Details are listed in the attached article titled, carotid artery stenting according to the 'tailored cas' algorithm performed in the very elderly patients: the thirty day outcome.No additional information was provided.
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(b)(4).The additional devices referenced are being filed under separate medwatch reports.The reported patient effect of stroke is a known observed and potential patient effect as listed in the acculink instructions for use (ifu).Although a conclusive cause for the reported patient effect, 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.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the information reviewed, there is no indication of a product deficiency.
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