The device was not returned for analysis.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 thrombosis are listed in the xience skypoint 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 subsequent 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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It was reported that on (b)(6) 2023, the patient, with a history of acute myocardial infarction of inferior wall / st elevation myocardial infarction (stemi) had 1 xience skypoint (3.5x18 mm) stent implanted.On (b)(6), 2023, the patient was re-admitted with stemi of inferior wall and thrombosed stent.Percutaneous transluminal coronary angioplasty (ptca) and thrombectomy were performed.There was no adverse patient sequela.Patient discharged to home on (b)(6) 2023.No additional information was provided.
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