BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 3843640 · Received May 28, 2014

    Report

    Report Number
    1820334-2014-00222
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 1, 2014
    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 IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A (B)(6) FEMALE PATIENT HAD UNDERGONE AAA REPAIR WITH ZENITH FLEX WITH LEFT APPROACH. THE PATIENT WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE PROCEDURE WAS CONDUCTED AS LABELED. TYPE 1A ENDOLEAK WAS CONFIRMED, SO AN EXTENSION WAS ADDITIONALLY PLACED. THE PROCEDURE WAS FINISHED AFTER CONFIRMING THE TYPE 1 ENDOLEAK WAS RESOLVED. ACCORDING TO ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2014, THE CONTRALATERAL ILIAC LEG GRAFT WAS PLACED WITH SHORT OVERLAP INSIDE THE CONTRALATERAL LIMB OF THE MAIN BODY. ON (B)(6) 2012, FOLLOW-UP CT ANGIO DID NOT CONFIRM ANEURYSM ENLARGEMENT. ON (B)(6) 2013, FOLLOW-UP CT ANGIO DID NOT CONFIRM ANEURYSM ENLARGEMENT. SINCE THE PATIENT FELT SICK WITH CONTRAST MEDIUM, FOLLOW-UP SIMPLE CT WERE PERFORMED SEVERAL TIMES OTHER THAN CT ANGIO DESCRIBED ABOVE. ON UNKNOWN DATE, A SIMPLE FOLLOW-UP CT SHOWED ANEURYSM ENLARGEMENT ACCORDING TO A RADIOLOGIST'S COMMENT. WITH THE RADIOLOGIST'S COMMENT, CT ANGIO WAS PERFORMED AS FOLLOW-UP. HOWEVER, NO SEVERE ANEURYSM ENLARGEMENT WAS OBSERVED. THE PHYSICIAN DECIDED TO CONTINUE THE FOLLOW-UP. ON 04/30/2014 MORNING, URGENT PROCEDURE WAS CONDUCTED DUE TO AAA RUPTURE. ANGIOGRAPHY CONFIRMED ENDOLEAK FROM JUNCTION PART BETWEEN CONTRALATERAL ILIAC LEG GRAFT AND MAINBODY. THEN, ANOTHER MANUFACTURER'S STENT GRAFT WAS ADDITIONALLY PLACED OVER THE CIA AND EIA COVERING THE PLACE WHERE ENDOLEAK WAS CONFIRMED. CONFIRMATORY ANGIOGRAPHY WAS PERFORMED SEVERAL TIMES AFTER THE ADDITIONAL PLACEMENT, AND THE PROCEDURE WAS FINISHED AFTER CONFIRMING THAT THE ENDOLEAK WAS RESOLVED. THE PATIENT REMAINS HOSPITALIZED. LOWERING OF BLOOD PRESSURE IS OBSERVED AS OF (B)(6) 2014. AS OF (B)(6) 2014, BLOOD PRESSURE IS STABILIZED THOUGH, WE CANNOT BE OPTIMISTIC ABOUT PATIENT'S CONDITIONS; RENAL DYSFUNCTION IS OBSERVED. IT IS POSSIBLE THAT LIVER DYSFUNCTION AND/OR INFECTIOUS DISEASE WILL BE OBSERVED HEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314638 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2707502

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization