(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction and the product was not returned as the stent remains in the anatomy.The reported patient effects of ischemia, thrombosis and surgery are listed in the supera instructions for use as a known potential patient effects.The lot history record (lhr) for this product could not be reviewed because the lot number was not reported.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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