BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2140357 · Received June 16, 2011

    Report

    Report Number
    1820334-2011-00299
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 17, 2011
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN (B)(6) MALE PATIENT WITH AAA AND IAA UNDERWENT AAA REPAIR. THE PATIENT'S ANATOMICAL FORM WAS DETERMINED AS SUITABLE FOR THE PROCEDURE BUT THE TRANSITION BETWEEN THE RIGHT COMMON ILIAC ARTERY AND THE EXTERNAL ILIAC ARTERY WAS CURVED MORE THAN 90 DEGREES. THE PROCEDURE WAS CONDUCTED AS LABELED AND A MAINBODY AND TWO ILIAC LEGS WERE PLACED. FROM AROUND ON (B)(6) 2011, THE PATIENT STARTED FEELING FATIGUE IN THE RIGHT LOWER LEG, BUT HAD NOT DONE ANYTHING FOR IT. AT THE FOLLOW UP ON (B)(6) 2011, CT ANGIOGRAPHY WAS PERFORMED BECAUSE THE RIGHT DORSAL PEDIS ARTERY PULSE WAS IMPALPABLE. IT SHOWED THAT THE CURVE LEVEL OF THE RIGHT ILIAC LEG GRAFT WAS REMAINED THE SAME, BUT THE RIGHT SIDE BECAME OCCLUDED COMPLETELY FROM THE POSITION OF THE PROXIMAL TIP OF THE LEFT ILIAC LEG GRAFT TO THE EXTERNAL ILIAC ARTERY. A COLLATERAL VESSEL FROM THE FEMORAL ARTERY WAS PROVIDING BLOOD FLOW TO PERIPHERAL. ON (B)(6) 2011, FEM-FEM BYPASS WAS PERFORMED. NECROSIS DUE TO ISCHEMIA LOWER LEG WAS NOT CONFIRMED. THE PATIENT WAS DOING FINE AFTER THE PROCEDURE. NO IMAGES WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC. NA F2563806

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention