BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® HYBRID VASCULAR GRAFT

    MDR report key: 5765201 · Received July 1, 2016

    Report

    Report Number
    2017233-2016-00608
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    June 3, 2016
    Report Date
    June 5, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, A PATIENT PRESENTED FOR AN ARTERIOVENOUS ACCESS PROCEDURE IN THE RIGHT UPPER ARM. ACCESS WAS GAINED THROUGH AN AXILLARY VEIN CUTDOWN. A VENOGRAM WAS PERFORMED. A PEEL-AWAY SHEATH WAS PLACED AND THE GORE HYBRID VASCULAR GRAFT WAS ADVANCED OVER A GUIDEWIRE. THE PEEL-AWAY SHEATH WAS REMOVED AND DEPLOYMENT WAS INITIATED WHEN THE DEPLOYMENT LINE BECAME STUCK AFTER ABOUT 2CM WAS DEPLOYED. IT WAS REPORTED SOME EXERTION WAS USED DURING ATTEMPTS TO RELEASE THE DEPLOYMENT LINE AND CONTINUE DEPLOYMENT. THE NITINOL REINFORCED SECTION (NRS) OF THE GORE HYBRID VASCULAR GRAFT FOLDED ON ITSELF DUE TO THE DEPLOYMENT LINE TENSION AND POSSIBLE LOSS OF WIRE. AS REPORTED, SOME OF THE NRS STRUTS HAD BECOME DISTORTED AND BENT. THE PATIENT'S VEIN WAS COMPROMISED IN THE PROCESS OF REMOVING THE DAMAGED NRS. THE NRS PORTION OF THE GRAFT WAS CUT OFF AND A GORE VIABAHN ENDOPROSTHESIS WAS PLACED THROUGH THE VASCULAR GRAFT AS A CONDUIT INTO THE VEIN. HEMOSTASIS WAS ACHIEVED AND THE PATIENT WAS STABLE AT THE CONCLUSION OF THE PROCEDURE. ON (B)(6) 2016, THE PATIENT EXPIRED OF UNKNOWN CAUSES. AS REPORTED, THE GORE DEVICES WERE PATENT AT THE TIME OF PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419640 GORE® HYBRID VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 14112777

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention PEEL-AWAY SHEATH, GUIDEWIRE