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 atrial fibrillation is determined to be synonymous with arrhythmia.Patient effect arrhythmia is listed in the xience sierra instructions for use as a known patient effect of coronary stenting procedures.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 on (b)(6) 2020 the patient presented with sepsis.Three xience sierra stents (3.0x38mm, 3.25x38mm, and 2.25x38mm) were implanted.On (b)(6) 2020, the patient was re-hospitalized with unspecified cardiovascular symptoms and atrial fibrillation.Unspecified treatment was provided and the final patient outcome is not known.No additional information was provided.
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