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 effects of embolism, ischemia, myocardial infarction, and angina are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, 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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Patient id: (b)(6).It was reported that the procedure was performed on (b)(6) 2020, to treat a lesion in the proximal left anterior descending (lad) artery.A 2.75 x 12 mm xience alpine stent was implanted.After stent deployment and post dilatation, slow flow was noted, with associated st changes and chest pain.Myocardial infarction was diagnosed, likely due to distal emolization.Medication was administered.The hospitalization was prolonged and the adverse patient effect resolved on (b)(6) 2020.No additional information was provided.
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