Clinical trial : (b)(4).Patient site id: (b)(6).It was reported that on (b)(6) 2022, a 21mm masters series heart valsalva aortic valves graft was successfully implanted.On (b)(6) 2022, the patient experienced non-st-elevation myocardial infarction in 2 vessel coronary artery disease.A percutaneous intervention (angioplasty/stent) was performed.The physician allege that myocardial infarction was caused by proximal stenosis of the venousinterponat.The device was reported to be working as intended.The patient was reported to be in stable condition.
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An event of non-st-elevation myocardial infarction was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
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