The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent 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; therefore, no product-related corrective action will be implemented in this case.
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It was reported that the patient has a history of non-st elevated myocardial infarction (nstemi).On (b)(6) 2022, xience skypoint stents (3.0x28mm, 3.5x08mm, 4.0x18mm) were implanted.On (b)(6) 2022, the patient was re-hospitalized for elevated troponin levels.No treatment was provided and the patient was discharged on (b)(6) 2022.No additional information was provided.
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