Date of event: date estimated.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints for thrombosis reported from this lot.Based on the case information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effect of thrombosis is listed in the xact instructions for use (ifu) as a known potential patient effect potentially associated with carotid stents and embolic protection systems.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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