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 death/expired and myocardial infarction 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.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.The xience skypoint des 2.25 x 12 referenced is filed under a separate medwatch report number.
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It was reported that the procedure was to treat a right posterior atrio-ventricular and right posterior descending lesions on 5/20/2021.Pre-dilatation was performed with semi-compliant balloon.A 2.25x18mm xience skypoint was deployed at 10 atmospheres without post dilatation.Then a 2.25x12mm xience skypoint was deployed at 16 atmospheres with post diliatation.No issue was noted during the procedure.On (b)(6) 2021 and (b)(6) 2022, the patient came to the hospital but no issue was noted on the patient's condition during those visits.On (b)(6) 2022, the patient died.Relation between the incident and the study is not determined.Per the physicians clinical decision the cause of death was due to acute myocardial infarction.It is unknown if an autopsy was performed.No angiography was performed.Prescribed anti-platelet drugs (clopidogrel, aspirin) were stopped being applied by the time the patient was released from hospital after percutaneous coronary interventional procedure.No additional information.
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