BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 512702 · Received February 20, 2004

    Report

    Report Number
    2953161-2004-00004
    Event Type
    Death
    Date Received
    February 20, 2004
    Date of Event
    January 21, 2004
    Report Date
    February 19, 2004
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED TO ER WITH A CONTAINED RUPTURED ANEURYSM. PHYSICIAN CHOSE TO ATTEMPT TO REPAIR THE ANEURYSM WITH THE EXCLUDER DEVICE. THE TRUNK-IPSILATERAL COMPONENT WAS DEPLOYED THROUGH THE RIGHT SIDE ACCESS AFTER ADVANCEMENT ON THE LEFT SIDE FAILED. CANNULATION OF THE CONTRALATERAL LEG HOLE RING WAS UNSUCCESSFUL, AND THE DECISION WAS MADE TO CONVERT THE PT TO OPEN SURGICAL REPAIR. UPON VISUALIZING THE SITUATION ONCE OPEN, THE PHYSICIAN DETERMINED THAT THE CONDITIONS WERE TOO SEVERE TO CONTINUE WITH STANDARD OPEN REPAIR. THROUGH THE OPEN ABDOMINAL CAVITY, THE PHYSICIAN WAS ABLE TO CANNULATE THE CONTRALATERAL LEG HOLE RING AND SUCCESSFULLY DEPLOY THE CONTRALATERAL LEG COMPONENT. THE LEFT ILIAC ARTERY WAS LEAKING, AND IN ATTEMPTS TO STOP THE LEAK, THREE ADDITIONAL CONTRALATERAL LEG COMPONENTS WERE USED TO EXTEND DISTALLY ON THE ILIAC ARTERY AND TO BRIDGE BETWEEN COMPONENTS. IN ANOTHER ATTEMPT TO STOP LEAKAGE, AN AORTIC EXTENDER WAS PLACED IN THE PROXIMAL NECK. FINAL ANGIO REVEALED NO LEAK AND CLOSURE OF THE PT BEGAN, HOWEVER 15 MINUTES INTO CLOSURE, THE PT EXPIRED. THE PT SUSTANINED SUBSTANTIAL BLOOD LOSS THROUGHOUT THE PROCEDURE. CAUSE OF DEATH WAS STATED TO BE COMPLICATIONS FROM BLOOD LOSS AND RELATED DIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLUDER BIFURCATED ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES, INC. WLG325 0309334-07

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death