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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effect of hypersensitivity is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.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) 2020 a xience sierra stent was implanted in an unspecified coronary artery.Since the procedure the patient has experienced hives, swelling in lips and hands.On (b)(6) 2020, the patient visited the emergency room due to the allergic reaction.Benadryl was administered during the emergency room visit.The patient was no further hospitalization from the emergency visit.There was no device issue reported.There was no additional adverse patient sequela.No additional information was provided.
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