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 ischemia are listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) 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.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) 2019, treating a target lesion in the proximal right coronary artery (rca).A 3.5 x 28 mm xience sierra stent and a 4.0 x 38 mm xience sierra stent were implanted.Post procedure, distal slow flow was noted.The patient experienced cardiac enzyme elevation and myocardial infarction was diagnosed.No treatment was provided and the event resolved on (b)(6) 2019.No additional information was provided.
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