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(s), 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 on (b)(6) 2020, the patient had a 2.50x33 mm xience sierra stent implanted.On (b)(6) 2020, the patient was re-hospitalized due to a congestive heart failure.The type of treatment was unspecified and the final patient outcome is unknown.No additional information was provided.
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