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.The reported patient effect of stenosis is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatments appear 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) 2019, the procedure was performed to treat a lesion in the 1st obtuse marginal artery.The 2.5 x 28 mm xience sierra stent was implanted at 12 atmospheres.Approximately 20 months post stenting procedure, on (b)(6) 2020, the patient experienced shortness of breath and fatigue.The patient was admitted for a coronary procedure and in-stent restenosis was noted in the obtuse marginal artery.A sculpting balloon was used.The event resolved without sequela and the patient was discharged home the same day.No additional information was provided.
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