BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1231645 · Received November 14, 2008

    Report

    Report Number
    2953161-2008-00376
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 13, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    THIS PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESIS. THE PHYSICIAN USED A 33MM EQUALIZER BALLOON ON THE CONTRALATERAL LIMB WHICH RUPTURED THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN IMPLANTED AN ILIAC EXTENDER COMPONENT DOWN TO THE LEVEL OF THE LEFT HYPOGASTRIC TO REPAIR THE RUPTURED COMMON ILIAC ARTERY, HOWEVER A DISTAL TYPE I ENDOLEAK WAS DISCOVERED. THE PHYSICIAN THEN CHOSE TO COIL EMBOLIZE THE HYPOGASTRIC AND IMPLANT ANOTHER ILIAC EXTENDER COMPONENT EXTENDING THE GRAFT INTO THE EXTERNAL ILIAC ARTERY. THE FINAL ANGIOGRAPHY REVEALED COMPLETE EXCLUSION OF THE ANEURYSM, RUPTURED ILIAC, AND NO ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES, INC. WLG325 06153001

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other