(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.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of dissection is listed in the xience prime everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.Although a relationship between the reported patient effect and the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design, or labeling.
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