BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1001911 · Received February 21, 2008

    Report

    Report Number
    2953161-2008-00025
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 21, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ANEURYSM GROWTH IN THE ABSENCE OF ENDOLEAKS HAS BEEN DEFINED AS ENDOTENSION IN THE LITERATURE. ONE HYPOTHESIS FOR THE SOURCE OF ENDOTENSION IS THE TRANSMURAL MOVEMENT OF SERIOUS FLUID ACROSS THE MATERIAL USED TO FABRICATE DEVICES USED TO TREAT THE AORTIC ABDOMINAL ANEURYSM. EVIDENCE SUPPORTING THIS HYPOTHESIS HAS BEEN GATHERED DURING SURGICAL CONVERSIONS, TRANSLUMBAR PUNCTURES OF THE AORTIC ABDOMINAL ANEURYSM, AND LAPAROSCOPIC EXPLORATION OF AORTIC ABDOMINAL ANEURYSM SAC CONTENTS. DUE TO THESE OBSERVATIONS GORE ELECTED TO PROVIDE A DESIGN ENHANCEMENT TO THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. THE DEVICE USED IN THIS PARTICULAR CASE WAS THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. PLEASE NOTE ATTACHED LIST OF ADDITIONAL DEVICES IMPLANTED IN THIS PATIENT: PCL161007/022243607, PCC121000/032051407.

    Description of Event or Problem · 1

    IN 2004, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. ANEURYSM ENLARGEMENT WITH ABSENCE OF AN ENDOLEAK WAS NOTED IN 2008. A REINTERVENTION TOOK PLACE ONE MONTH LATER, TO RELINE THE DEVICES USING ADDITIONAL ENDOPROSTHESIS. THE PROCEDURE WENT WELL.

    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 021260305

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention