BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2618998 · Received June 11, 2012

    Report

    Report Number
    2953161-2012-00124
    Event Type
    Death
    Date Received
    June 11, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 14, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS. THE FINAL ANGIOGRAM SHOWED PROXIMAL TYPE 1 ENDOLEAK. THE PHYSICIAN ADDITIONALLY PLACED A PXA AND PERFORMED TOUCH-UP BALLOONING WITH THE CODA BALLOON. THE ENDOLEAK WAS RESOLVED AND THE PT WAS MOVED TO THE ICU. THEN 20-30 MINUTES LATER, THE PT WENT INTO SHOCK. AN EMERGENCY CT WAS PERFORMED WHICH REVEALED THE ASCENDING AORTA RUPTURE DUE TO THE AORTIC DISSECTION. IT CAUSED THE HEMORRHAGIC SHOCK. ALTHOUGH THE EMERGENCY SURGERY TO REPLACE THE RUPTURED ASCENDING AORTA WITH VASCULAR GRAFT WAS PERFORMED, THE PT EXPIRED ON (B)(6) 2012. THE AUTOPSY WAS NOT PERFORMED. THE PHYSICIAN STATED THAT THE OVER-INFLATION OF CODA BALLOON AT THE PROXIMAL TOUCH-UP TO THE PXA MADE A DISSECTION AND THE DISSECTION EXTENDED PROXIMALLY TO THE ASCENDING AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10067063

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death