Per operative notes: clotted mitral mechanical prosthesis.3rd time re-do mvr.1st mvr in 1987, re-do for clotted valve in 1998, 2nd re-do for clotted valve/pannus from a st jude valve in 2013, then this on-x valve implanted.Valve came out easily with no further dissection suggesting that there may be a chronic infective element in this patient (per surgeon).The latter is not conclusive at this time.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 5480, 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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