On (b)(6) 2019 a sjm masters series heart valve w/teflon cuff was implanted in the diabetic and dialysis patient, a supra-annular position using non-everting mattress suture technique with the pledgets on the outflow side.An abbott sizer (model#: 905) was used in the surgery.It was confirmed by the x-ray fluoroscopy during a follow-up that one of the leaflets on the valve was not moving, and on (b)(6) 2020, a re-do avr was performed.The 25mm sjm master series heart valve w/ teflon cuff was explanted and replaced with a 23mm sjm master series heart valve w/teflon cuff (serial # (b)(4)).Upon explant of the valve, thrombus was confirmed to be adhered at the pivot guard hinge, impeding the leaflet mobility.It was reported that international normalized ratio of prothrombin time (inr) was maintained at 2.1 before the re-do avr, and the patient has had been administered anticoagulants.The pathological examination concluded that the issue was due to thrombus, but the surgeon requested pannus formation on the valve, also.
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The reported thrombus in the recessed pivot areas, impeding leaflet mobility, was confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The root cause of the thrombus could not be conclusively determined.
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