Hold ng.4/2/15 pt with on-x mitral valve replacement (mvr) presented with valve thrombosis, nyha grade iii.Severe mitral regurgitation due to restricted motion of posterior leaflet.Re-operation performed, operative notes show surgeon states pathology is stuck mitral prosthesis with clot and movement of one leaflet."surgeon reports corrective procedure is re-do mvr with another bileaflet mechanical valve.Pt recovered from the surgery." valve thrombosis is by definition in the aats/sts guidelines a valve-related event and is therefore reportable.Valve thrombosis is an expected adverse event, as defined in the objective performance criteria in fda heart valve guidance, and iso 5840, and this occurrence is well-within expected rate.Correction of the event required re-operation, classified as a "serious injury." therefore.It is reportable as an mdr.
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