BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 1922089 · Received December 7, 2010

    Report

    Report Number
    2017233-2010-00542
    Event Type
    Injury
    Date Received
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2010 A GORE HYBRID VASCULAR GRAFT WAS IMPLANTED IN AN AV ACCESS APPLICATION. THE PROCEDURE WAS PERFORMED IN THE PATIENT'S LEFT UPPER-ARM, FROM THE AXILLARY ARTERY TO THE AXILLARY VEIN. THE HYBRID GRAFT WAS FOUND NOT TO BE FUNCTIONING AND WAS ABANDONED THE FIRST WEEK IN (B)(6). THE GORE-HYBRID VASCULAR GRAFT HAD BEEN CANNULATED.

    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 8263842

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention