(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 angina is listed in the xience prime 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(s), 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.
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It was reported that on (b)(6) 2014, a 2.5x12mm xience prime was successfully implanted in the distal circumflex (cx) coronary artery lesion.On (b)(6) 2017, the patient experienced aggravated chest tightness with numbness in the right upper limbs.On (b)(6) 2017, the patient was hospitalized and coronary imaging was performed.Restenosis was noted in the distal cx, xience prime stent.Another stent was implanted as treatment and medication was provided.The event resolved.No additional information was provided regarding this issue.
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