It was reported that on (b)(6) 2023, the patient, with a history of st elevation myocardial infarction (stemi) and chronic ischemic heart disease, had 1 xience skypoint (2.75x15mm) stent implanted.On (b)(6) 2023, the patient was re-admitted with coronary thrombosis and cardiac disturbances.Thrombectomy was performed.There was no adverse patient sequela.The patient was discharged home on (b)(6) 2023.No additional information was provided.
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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 effect of thrombosis is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, 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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