(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.The lot history record for this product could not be reviewed because the lot number was not reported.The reported patient effects of thrombosis and pain are listed in the supera instructions for use as known potential patient effects.Based on the case information and related record review, 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.The additional supera stent referenced is being filed under a separate medwatch report number.
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