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 sepsis is not listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures, however sepsis is listed as a foreseeable event in the no-fault errors for coronary and endovascular products risk assessment.A conclusive cause for the reported patient effect, 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 a 2.5x18mm xience sierra stent was implanted on (b)(6) 2020.The patient presented with a non-st elevated myocardial infarction (stemi) before the procedure.On (b)(6) 2020, the patient was re-admitted with sepsis.Unspecified treatment was performed, and the final patient outcome is unknown.No additional information was provided.
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