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 hypertension is listed in the xience sierra, everolimus eluting coronary stent system instructions for use, 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.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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It was reported that on (b)(6) 2020, a 2.75x08mm and 2.75x18mm xience sierra stent were implanted without a device issue noted.On (b)(6) 2020, the patient was admitted to the hospital due to hypertension.The patient was discharged home 4 days later.The device relationship to the event is unknown.No additional information was provided regarding this issue.
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