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) 2019 the patient presented with non-st elevated myocardial infarction (nstemi) therefore the 3.25x15mm, 3.25x38mm, and 3.50x38mm xience sierra stents were implanted.On (b)(6) 2019 the patient was re-admitted with other [unspecified] cardiovascular symptoms and artery complications.Percutaneous transluminal coronary angioplasty (ptca) was performed however the final patient outcome is unknown.No additional information was provided.
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