BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 1001912 · Received February 21, 2008

    Report

    Report Number
    2017233-2008-00068
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 21, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE; THE IMPLANT DATE REPORTED TO GORE WAS 2001. A DATE OF 2001 WAS ASSIGNED. A REVIEW OF THE MANUFACTURING PAPERWORK COULD NOT BE CONDUCTED AS NO LOT NUMBERS ARE AVAILABLE TO GORE. 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 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.

    Description of Event or Problem · 1

    IN 2001, THIS PATIENT WAS IMPLANTED WITH A GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. IN 2008, THE PHYSICIAN EXPLANTED AND DISCARDED THE DEVICE. AS REPORTED, THE PHYSICIAN FELT THAT THERE WAS ANEURYSM ENLARGEMENT AND THAT THE ANEURYSM ENLARGEMENT WAS DUE TO ENDOTENSION, AS THERE WAS NO ENDOLEAK REVEALED DURING FOLLOW-UP. THE PATIENT IS REPORTEDLY DOING WELL. NO FURTHER INFORMATION IS AVAILABLE TO GORE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention