The device was not returned for evaluation.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 effect, 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.
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It was reported that the patient presented with a myocardial infarction and on (b)(6) 2020 three xience sierra stents (2.5 x 18, 3.0 x 38, 3.5 x 28) were implanted.On (b)(6) 2020, the patient was re-hospitalized with chronic gastrojejunal ulcer with hemorrhage.Treatment included placement of a pacemaker.The final patient outcome is unknown.No additional information was provided.
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