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.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effect of intimal dissection is listed in the xience xpedition, everolimus eluting coronary stent system, instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
|
It was reported that the procedure was performed to treat a 90% stenosed, moderately tortuous, and moderately calcified lesion in the left anterior descending artery.Following pre-dilatation, a 3.0x15mm xience xpedition stent was implanted at 16 atmospheres.Fluoroscopy after stenting showed a proximal edge dissection.An unspecified xience xpedition stent was deployed to successfully treat the dissection.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
|