BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 3195479 · Received June 20, 2013

    Report

    Report Number
    2017233-2013-00383
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    A GORE HYBRID VASCULAR GRAFT WAS USED DURING A DIALYSIS ACCESS PROCEDURE. THE DEVICE WAS ADVANCED THROUGH A PEEL-AWAY SHEATH WITHOUT THE USE OF GUIDEWIRE. DURING DEVICE DEPLOYMENT, THE LINE BECAME TWISTED AS WELL AS THE NITINOL REINFORCED SECTION (NRS) OF THE HYBRID VASCULAR GRAFT. APPROXIMATELY 2/3RDS OF THE NRS DEPLOYED WITH THE DEPLOYMENT HALTED AND THE DEVICE WAS UNABLE TO COMPLETE DEPLOYMENT. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PT WAS FINE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281086 GORE HYBRID VASCULAR GRAFT DSY/PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 10869735

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR