BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED TISSUE VALVE

    MDR report key: 2000950 · Received February 18, 2011

    Report

    Report Number
    3001743903-2011-00005
    Event Type
    Injury
    Date Received
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT SURGERY. POSTOPERATIVELY, THE PATIENT BECAME SYMPTOMATIC WITH AN ELEVATED GRADIENT. AN ECHO REVEALED VALVE THROMBOSIS, OBSTRUCTED STRUTS AND A STENOTIC LEAFLET. THE PATIENT WAS PUT ON WARFARIN FOR A MONTH AND THE GRADIENT DECREASED TO AN ACCEPTABLE RANGE. THE VALVE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC STENTED TISSUE VALVE NONE LWR ST JUDE MEDICAL BRASIL LTDA.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention