It was learned that a patient with a non-(b)(6) 23mm on-x mechanical valve developed large lvot pseudoaneurysm approximately 1 year post implant and had extensive testing, but no clear etiology/mechanism for the mechanical valve failure and presumed culture negative endocarditis.She underwent redo bio bentall ((b)(6) 2023) and the mechanical valve was replaced with a 25mm (b)(6) aortic valved-conduit.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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