BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS

    MDR report key: 4110215 · Received September 23, 2014

    Report

    Report Number
    2017233-2014-00493
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    May 5, 2014
    Report Date
    September 25, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RADIOGRAPHIC IMAGE EVALUATION COMPLETED. CONTRAST APPEARS WITHIN THE DISTAL PORTION OF THE RIGHT COMMON ILIAC ARTERY LESION. THE ORIGIN OF THE CONTRAST CANNOT BE CONFIRMED WITH AVAILABLE IMAGES.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. INVESTIGATION IN PROGRESS PENDING THE COMPLETION RADIOGRAPHIC IMAGE EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED, THE SUBJECT DEVELOPED A TYPE III ENDOLEAK COMING FROM THE GORE VIABAHN® ENDOPROSTHESIS WHICH WAS PLACED INTO THE RIGHT GORE EXCLUDER ENDOPROSTHESIS LIMB. THE SUBJECT UNDER WENT AN ANGIOGRAM AND AN ENDOLEAK REPAIR USING ICAST FOR REPAIR. REPORTEDLY, THE ENDOLEAK APPEARED TO LEAK FROM GUTTER FORMED BY INTERACTION BETWEEN INTERNAL AND EXTERNAL RIGHT ILIAC ARTERY STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589940 GORE VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES 10790526

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention