Date of event estimated as (b)(6) 2013.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.Based on the case information, a conclusive cause for the reported patient effects of stroke and filter thrombosis, and the relationship to the product, if any, cannot be determined.The reported treatment with medication and hospitalization was likely due to case circumstances.The reported patient effects of stroke and filter thrombosis are listed in the emboshield nav6 instruction for use, as known possible adverse events that may be associated with embolic protection systems.There is no indication of a product quality issue with respect to manufacture, design or labeling.The udi number is unknown as the part and lot #s were not provided.Literature title: carotid artery stenting vs.Carotid endarterectomy: a comparative non-randomized study in two university hospitals.
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