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 myocardial infarction and embolism is listed in the xience sierra everolimus eluting coronary stent systems instructions for use ifu) as known patient effects of coronary procedures.A conclusive cause for the reported patient effects, 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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Patient id: (b)(6).It was reported that the procedure was performed to treat a target lesion in the mid left anterior descending (lad) artery.Three xience sierra stents were implanted: a 2.25 x 23 mm, a 3.0 x 28 mm, and a 3.5 x 23 mm.Post procedure, the patient experienced a cardiac enzyme elevation.The patient was diagnosed as having a myocardial infarction, which was suspected to be caused by distal embolization of plaque material during the procedure.The patient did not experience any chest pain, and there was no hemodynamic instability or electrocardiogram change.No intervention was performed and the event resolved on the day of discharge (b)(6) 2020.There was no clinically significant delay in the procedure.No additional information was provided.
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