BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 2366763 · Received December 2, 2011

    Report

    Report Number
    2017233-2011-00654
    Event Type
    Injury
    Date Received
    December 2, 2011
    Report Date
    November 30, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A GORE HYBRID VASCULAR GRAFT WAS IMPLANTED IN AN AV ACCESS APPLICATION. THE PROCEDURE WAS IN THE PT'S AUXILIARY VEIN. APPROX TWO WEEKS AFTER IMPLANTATION, THE GRAFT THROMBOSED AND A THROMBECTOMY WAS PERFORMED. THE PHYSICIAN NOTICED BLEEDING FROM TWO HOLES IN THE GRAFT WHERE THE NITINOL REINFORCED SECTION (NRS) MEETS THE EPTFE SECTION. A HEMATOMA WAS FOUND A FEW CENTIMETERS PROXIMAL TO THE NRS. THE HEMATOMA WAS EVACUATED. A COVERED STENT WAS IMPLANTED TO STOP THE BLEEDING. THREE DAYS AFTER THE INTERVENTION, THE PT HAD ARM SWELLING DUE TO THE HEMATOMA, THE GRAFT WAS EXPLANTED ON (B)(6) 2011. REPORTEDLY, THE GRAFT HAD NOT 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 8965513

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention