BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 3001630 · Received March 7, 2013

    Report

    Report Number
    2017233-2013-00121
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 6, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER INFORMATION WAS SUPPLIED; THEREFORE, NO REVIEW OF THE MANUFACTURING PAPERWORK COULD BE PERFORMED. THE DEVICE REMAINED IMPLANTED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. WITHOUT ADDITIONAL INFORMATION IT IS IMPOSSIBLE TO FURTHER INVESTIGATE THIS EVENT.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE IN (B)(6) 2013, TWO GORE HYBRID VASCULAR GRAFTS WERE IMPLANTED IN AN AORTIC DEBRANCHING PROCEDURE. THE HYBRID GRAFTS WERE USED FOR BYPASSING BOTH RENAL ARTERIES. THE IMPLANTATION WAS SUCCESSFUL. IT WAS REPORTED TO GORE THAT LATER THE SAME DAY, ONE OF THE HYBRID GRAFTS OCCLUDED. A THROMBECTOMY PROCEDURE WAS NOT SUCCESSFUL AND THE KIDNEY HAD TO BE REMOVED. THE GRAFT REMAINED IMPLANTED. IT WAS STATED THAT THE GRAFT WAS NOT KINKED. THE DEBRANCHING WAS PLANNED TO BE DONE IN TWO SESSIONS WITHIN A COUPLE WEEKS, THEREFORE, THE PATIENT WAS FULLY HEPARINIZED INSTEAD OF DOUBLE PLATELET ANTI-COAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97688 GORE HYBRID VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability