BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABIL BILIARY ENDOPROSTHESIS

    MDR report key: 2803015 · Received October 16, 2012

    Report

    Report Number
    3003910212-2012-00032
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    October 3, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FGE
    PMA / PMN Number
    K081184
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GORE HAS REQUESTED ADDITIONAL INFO FROM THE AUTHOR REGARDING THE CIRCUMSTANCES OF THE REPORT AND PT RELATED INFO. ABSTRACT CITATION: AN EVAL OF FULLY COVERED SELF-EXPANDING STENTS (FCSEMS) IN BENIGN BILIARY STRICTURES (BBS) AND COMPLEX BILE LEAKS. PROGRAM NO. P1201. ACG 2012 ANNUAL SCIENTIFIC MEETING ABSTRACTS. LAS VEGAS, NV: AMERICAN COLLEGE OF GASTROENTEROLOGY. THE DEVICE HAS NOT BEEN RETURNED AND THE LOT NUMBER HAS NOT BEEN MADE AVAILABLE. CONSEQUENTLY, A DIRECT PRODUCT EVAL AND REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED. IT SHOULD BE NOTED THAT GORE VIABIL BILIARY ENDOPROSTHESIS IS NOT INDICATED FOR REMOVAL IN THE TREATMENT OF BENIGN BILIARY STRICTURES.

    Description of Event or Problem · 1

    REVIEW OF THE ABSTRACT, "AN EVAL OF FULLY COVERED SELF-EXPANDING STENTS (FCSEMS) IN BENIGN BILIARY STRICTURES (BBS) AND COMPLEX BILE LEAKS" REVEALED THAT A PT HAD A GORE VIABIL BILIARY ENDOPROSTHESIS PLACED FOR A BENIGN BILIARY STRICTURE WHICH OCCLUDED 27 DAYS POST IMPLANTATION AND HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABIL BILIARY ENDOPROSTHESIS FGE/CATHETER, BILIARY, DIAGNOSTIC FGE W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention