(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 event.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.The reported patient effect of intimal dissection is listed in the xience prime long length (ll), everolimus eluting coronary stent system (eecss), instructions for use (ifu) as a known patient effect of a coronary stenting procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|
It was reported that the procedure was to treat a de novo lesion in a moderately calcified proximal left anterior descending artery that did not have any tortuosity.A 3.0 x 38 mm xience prime stent was implanted.However, during implantation, a proximal-edge dissection was noted which was treated with another 3.0 x 38 mm xience prime stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
|