Patient with on-x mitral valve replacement (mvr) presented with valve thrombosis.Patient is known to be non-compliant with anticoagulation therapy.Re-operation performed, re-do mvr with another bileaflet mechanical valve (onxm-25).Intra-operatively, surgeon confirmed thrombus on the mitral valve.Patient 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." it is therefore reportable as an mdr.
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