On (b)(6) 2018, a 31mm masters valve was implanted in the mitral position in a patient with normal right ventricular function.During device prep, the leaflets of the valve were tested and observed with good mobility.The implant site was debrided and after suturing, the physician observed movement of the leaflets with a leaflet tester.While the chest was open, echocardiogram revealed a blocked leaflet.The valve was repositioned with a valve holder, but obstruction was still observed.The valve was explanted and replaced with a second 31mm masters valve.The explanted valve's leaflets were tested again and were seen moving, but one of the leaflets had less mobility.Post-procedure, insufficiency of the right ventricle was observed and the patient was put on extracorporeal membrane oxygenation (ecmo).On (b)(6) 2018 (five days post-op), the second 31mm masters valve was observed with blocked leaflets, and it was explanted and a medtronic hancock tissue valve (unknown size) was implanted.Thrombus was noted on the second 31mm masters valve and per report, the user believes the first valve was due to the valve performance and the second valve's obstruction was due to thrombus from the effects of ecmo.
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