The age and weight were obtained from the index procedure date on (b)(6) 2020.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.It should be noted that the reported patient effect(s) of angina and stenosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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.
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Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with a recent non-st elevated myocardial infarction (nstemi) and in-stent restenosis in the distal left anterior descending (lad) coronary artery.Pre-dilatation was performed and a 2.5x15mm xience sierra stent was implanted with acceptable results, 0% residual stenosis and no complications.On (b)(6) 2021, the patient was admitted to the hospital with stable angina.Per imaging, severe in-stent restenosis of the target distal lad xience sierra was noted.Another revascularization was performed as treatment.The event resolved without sequela.No additional information was provided regarding this issue.
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