Per operative notes: stuck mitral mechanical prosthesis.Fluoroscopy showed one leaflet stuck in closed position and other leaflet only had approx 30-degree of mobility.Patient symptom - nyha iv, pulmonary edema, inr at base hospital is 1.29 - subtherapeutic.Surgeon noted organized thrombus in both hinge mechanisms.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.No trend is seen.Correction of the event required re-operation, classified as a "serious injury".Therefore it is reportable as an mdr.
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