BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 2261588 · Received September 14, 2011

    Report

    Report Number
    2017233-2011-00474
    Event Type
    Malfunction
    Date Received
    September 14, 2011
    Date of Event
    August 19, 2011
    Report Date
    September 14, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 1

    A GORE HYBRID VASCULAR GRAFT WAS USED FOR THE TREATMENT OF AN OCCLUDED NATIVE AV FISTULA. REPORTEDLY, DURING THE DEPLOYMENT OF THE NITINOL REINFORCED SECTION (NRS), APPROXIMATELY 3/4TH'S OF THE NRS LENGTH WAS DEPLOYED WHEN THE DEPLOYMENT LINE BROKE. A CONQUEST HIGH-PRESSURE BALLOON WAS USED TO COMPLETE DEPLOYMENT OF THE NRS. A GORE VIABAHN ENDOPROSTHESIS WAS DEPLOYED INSIDE THE NRS TO EXTEND THE TREATMENT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HYBRID VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES WLG417 9235283

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR GORE VIABAHN ENDOPROSTHESIS| CONQUEST HIGH PRESSURE BALLOON