BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 3010935 · Received March 7, 2013

    Report

    Report Number
    2017233-2013-00119
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    June 29, 2012
    Report Date
    February 13, 2013
    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

    REVIEW OF DEVICE MFG RECORD HISTORY CONFIRMED DEVICE MET PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A GORE HYBRID VASCULAR GRAFT WAS IMPLANTED IN AN A-V ACCESS APPLICATION. THE PROCEDURE WAS PERFORMED IN THE PT'S UPPER ARM, FROM A PREVIOUSLY IMPLANTED GRAFT IN THE INFLOW ARTERY TO THE AXILLARY VEIN. ON (B)(6) 2012, THROMBECTOMY AND ANGIOPLASTY WERE PERFORMED. A STENT (UNK MFR) WAS PLACED IN THE INTRAGRAFT STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98443 GORE HYBRID VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 9484478

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability