(b)(4).The device was not returned for evaluation.The reported patient effect of dissection is listed in the xience prime ll instructions for use as a known patient effect of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Based on the case information and related record review, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
|