Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient presented with a recent non-st elevated myocardial infarction (nstemi).No pre-dilatation was performed.A 2.75x33mm and 2.75x18mm xience stent were implanted in the left anterior descending (lad), coronary artery lesion.A 2.75x18 and a 2.75x8mm xience stent were implanted in the diagonal coronary artery, 80% stenosed lesion.Reportedly, stent placements angiographic appearance was acceptable and post-dilatation was performed.The end result was timi flow 3 and 0% diameter stenosis.Post-procedure, the patient's troponin increased and a new myocardial infarction (mi) was diagnosed.The patient had an intracranial bleed with herniation worsened by medical therapy for mi and had become unresponsive.On (b)(6) 2020, the patient expired.Per physician, the event was unrelated to the device and unrelated to the procedure.There was no device malfunction.No additional information was provided regarding this issue.
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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 effect(s) of myocardial infarction and death are listed in the xience xpedition everolimus eluting coronary stent systems instructions for as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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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