BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE ACUSEAL VASCULAR GRAFT

    MDR report key: 3581363 · Received January 7, 2014

    Report

    Report Number
    2017233-2014-00002
    Event Type
    Injury
    Date Received
    January 7, 2014
    Date of Event
    November 12, 2013
    Report Date
    December 12, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K130215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE MANUFACTURING RECORD HISTORY CONFIRMED DEVICE MET PRE-RELEASE SPECIFICATIONS. ATTEMPTS TO OBTAIN THE INFORMATION REQUIRED FOR THIS FORM WERE MADE BY W. L. GORE & ASSOCIATES, INC.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT WAS IMPLANTED WITH A GORE ACUSEAL VASCULAR GRAFT. REPORTEDLY, THE GORE ACUSEAL VASCULAR GRAFT THROMBOSED IMMEDIATELY AFTER SURGERY. PATIENT WAS NEGATIVE FOR HEPARIN ANTIBODIES AND POSITIVE FOR HYPERCOAGUABILITY. THE PATIENT WAS REFERRED TO HEMATOLOGY FOR TREATMENT. THE GORE ACUSEAL VASCULAR GRAFT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8727 GORE ACUSEAL VASCULAR GRAFT DSY/PROSTHESIS VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 4067777PP006

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention