The device was not returned for evaluation as it remains implanted in the patient.A review of the lot history record identified no manufacturing non-conformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effects, 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 xience sierra stent was implanted.On (b)(6) 2020, the patient was re-admitted with other cv symptoms, and acute kidney failure.Unspecified treatment was administered to the patient.The final patient outcome is unknown.No additional information was provided.
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