Date of death estimated on (b)(6) 2013.Date of event estimated as (b)(6) 2013.Implant date 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 effect of death, and the relationship to the product, if any, cannot be determined.The reported patient effect of death is listed in the xact instructions for use as a known possible adverse event that may be associated with carotid stents.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.The additional patient effects referenced are filed under a separate medwatch report number.
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It was reported through a research article identifying the xact carotid artery stent that may be related to death, transient ischemic attack, hypotension, restenosis, and bradycardia.Specific patient information is documented as unknown.Details are listed in the article, carotid artery stenting vs.Carotid endarterectomy: a comparative non-randomized study in two university hospitals.
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