(b)(4).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.It should be noted that the reported patient effect of prolapse is listed in the xience sierra, everolimus eluting coronary stent systems instructions for 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 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.
|
Patient id: (b)(6).It was reported that on (b)(6) 2019, a percutaneous coronary intervention (pci) was performed.Pre-dilatation was performed on the proximal right coronary artery (rca) lesion and a 4.0x33mm xience sierra stent was implanted without a device issue reported.Following, a distal plaque shift was observed, treated with a 3.5x15mm xience sierra stent.The event resolved without sequela.There was 0% residual stenosis and timi grade 3.No additional information was provided regarding this issue.
|