BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROTHESIS

    MDR report key: 2803182 · Received September 29, 2006

    Report

    Report Number
    2017233-2006-00386
    Event Type
    Injury
    Date Received
    September 29, 2006
    Date of Event
    September 25, 2006
    Report Date
    September 28, 2006
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE: THIS EVENT INVOLVES ANOTHER DEVICE: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2004, A PT UNDERWENT SUCCESSFUL REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING THE GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. DURING THE ONE YEAR FOLLOW UP APPOINTMENT, A CT STUDY WAS CONDUCTED WHICH DEMONSTRATED ANEURYSM GROWTH WHICH CONTINUED TO BE SEEN ON A (B)(6) 2006 CT SCAN. THE PT WAS BROUGHT BACK TO SURGERY ON (B)(6) 2006, FOR BOTH A RELINING OF THE GRAFT USING TWO ILIAC EXTENDER COMPONENTS AND THE RELEASE OF FLUID FROM THE ANEURYSMAL SAC VIA AN ABDOMINAL LAPAROTOMY. THE PHYSICIAN BELIEVES THE ANEURYSM GROWTH WAS DUE TO ENDO-TENSION. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES, INC. WLG325 03057763

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention