Pt with on-x mitral valve replacement (mvr) presented with valve thrombosis, in ex-tremis, and pulmonary edema.Re-operation performed, operative notes show surgeon states pathology is fresh blood clots noted above and below as well as the hinge mechanism of the leaflets.Surgeon reports corrective procedure is re-do mvr with another bileaflet mechanical valve.Pt recovered from the surgery.This pt had a prior on-x mvr and it also clotted.This was previously reported to fda on mfr# 1649833-14-07.At that time, pt was not taking any anticoagulation meds, at all.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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