(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.It should be noted that the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use, states: note the product use by (expiration) date specified on the package (product label).The investigation determined the device expiration issue appears to be related to the use error.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
|