BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® HYBRID VASCULAR GRAFT

    MDR report key: 4242787 · Received November 11, 2014

    Report

    Report Number
    2017233-2014-00580
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 15, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER WAS NOT SUPPLIED; THEREFORE, NO REVIEW OF THE MANUFACTURING RECORDS COULD BE PERFORMED.

    Description of Event or Problem · 1

    A GORE® HYBRID VASCULAR GRAFT WAS IMPLANTED ACROSS THE PATIENT'S ELBOW IN A FOREARM LOOP. REPORTEDLY, FOLLOW-UP IMAGING WAS NOT PERFORMED. THE PATIENT RETURNED AT A LATER DATE (DATE UNKNOWN) WITH A SWOLLEN ARM. IT WAS FOUND THE NITINOL REINFORCED SECTION OF THE GORE® HYBRID VASCULAR GRAFT HAD KINKED DURING IMPLANTATION. A GORE® VIABAHN® ENDOPROSTHESIS WAS DEPLOYED IN THE NITINOL REINFORCED SECTION OF THE GORE® HYBRID VASCULAR GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725562 GORE® HYBRID VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention