BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 860727 · Received June 4, 2007

    Report

    Report Number
    2017233-2007-00156
    Event Type
    Injury
    Date Received
    June 4, 2007
    Date of Event
    May 7, 2007
    Report Date
    June 1, 2007
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: DEVICE PXC121000/LOT IS INCLUDED IN THIS EVENT AND IS ASSOCIATED WITH SITE 2953161.

    Description of Event or Problem · 1

    IN 2007 THE GORE EXCLUDER AAA ENDOPROSTHESIS WAS EXPLANTED FROM A PATIENT. IT WAS SUSPECTED THAT A PRE-EXISTING INFECTION LED TO THE INFECTION OF THE EXCLUDER DEVICES. THE PATIENT WAS CONVERTED TO AN OPEN REPAIR AND IS REPORTED TO HAVE TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES, INC. WLG325 04543855

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention