Patient id: (b)(6).It was reported that on (b)(6) 2020, a 3.25 x 33 mm xience xpedition stent was successfully implanted in the mid left anterior descending (lad) artery.The patient was discharged to home the following day.On(b)(6) 2021, the patient was re-hospitalized with heart failure and a myocardial infarction.A coronary angiogram was performed and showed 70-80% stenosis in the left main coronary artery and 70% stenosis in the proximal lad, proximal to the target lesion.On (b)(6) 2021, revascularization was performed, with implant of a 3.5 x 18 mm xience stent in the left main and lad arteries.The event resolved on (b)(6) 2021.No additional information was provided.
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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 stenosis and myocardial infarction are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use 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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