It was reported that the procedure was to treat a de novo lesion located in the left circumflex artery that was 90% stenosed.After implantation of the 4.00x12mm xience xpedition stent, and post dilatation with a 4.0x8mm nc balloon, a distal edge dissection was observed.A 3.5x12mm xience xpedition stent was implanted as treatment.There was no adverse patient sequela.No additional information was provided.
|
The device was not returned for analysis.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 effect of dissection is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) 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.
|