The device was not returned for evaluation.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of occlusion and hypersensitivity are listed in the xience v everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The udi is unknown because the part number and lot number were not provided.
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