BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3122494 · Received May 14, 2013

    Report

    Report Number
    2953161-2013-00065
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 24, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    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

    ADDITIONAL COMPONENTS IMPLANTED ON (B)(6), 2011: PXL161207/9461851, PXC121400/9481940, PXL161207/9398341, PXA230300/9553601. RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS. BOTH DISTAL ENDS OF THE DEVICE LANDED AT THE EXTERNAL ILIAC ARTERIES. THEREFORE, THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND THE LEFT INTERNAL ILIAC ARTERY WAS BYPASSED WITH THE LEFT EXTERNAL ILIAC ARTERY. THE PROCEDURE SUCCESSFULLY ENDED. THE ANEURYSM MEASURED 62MM. ON (B)(6) 2012, FOLLOW-UP ULTRASOUND ECHO WAS PERFORMED. THE ANEURYSM MEASURED 60MM. ON (B)(6) 2012, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED. THE ANEURYSM MEASURED 50MM. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE HOSPITAL WITH FEVER OF 38.4 C AND ABDOMINAL AORTIC PAIN. COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED THAT THE ANEURYSM HAD RUPTURED DUE TO SAC PRESSURIZATION CAUSED BY A TYPE 2 ENDOLEAK. A SURGICAL CONVERSION WAS EMERGENTLY PERFORMED WHEREBY THE EXCLUDER DEVICE WAS REMOVED AND REPLACED BY A VASCULAR GRAFT. THE PATIENT TOLERATED THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212883 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 9402884

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R