BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 3231840 · Received July 12, 2013

    Report

    Report Number
    1820334-2013-00286
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A (B)(6) MALE AT THE TIME OF INITIAL IMPLANT UNDERWENT AN AAA REPAIR ON (B)(6) 2012. THE INITIAL IMPLANT WAS DONE WITH A FLEX MAIN BODY ON THE RIGHT SIDE. PLACED ON THE LEFT WERE TWO ILIAC LEG. DOCTOR EXTENDED JUST AS PRECAUTION. RESULT WAS GOOD AND NO ISSUES. ON APPROX (B)(6) 2013 AFTER NUMEROUS ANGIO IMAGES A POSSIBLE TYPE II OR III ENDOLEAK WAS DETECTED. THE PHYSICIAN DID NUMEROUS ANGIO IMAGES ABOUT A MONTH AGO TO DETERMINE THE SOURCE AND COULD NOT DETERMINE IT. DECIDED TO RELINE GRAFT. INITIALLY THE PHYSICIAN PUT A BALLOON UP AND DID A RUN ON EACH SIDE TO DETERMINE IF THE LEAK WAS IN A LIMB. SEEMED TO BE MORE PROMINENT ON THE RIGHT SIDE. THE PHYSICIAN MOVED THE BALLOON UP AND DOWN AND IT SEEMS THAT THERE WAS A LEAK IN THE BIFURCATION OF THE GRAFT. THROUGH THE MIDDLE. DECIDED TO TRY AND CREATE A NEW BIFURCATION. USED 2 ZENITH LEG EXTENSION GRAFTS. PLACED THEM ON EACH SIDE ABOVE THE GRAFT BIFURCATION OVER A LUNDERQUIST WIRE ON BOTH SIDES. BALLOONED WITH TWO 14 X 2 BALLOONS. INFLATING SIMULTANEOUSLY. DID A RUN AND STILL HAD A LEAK IN THE SAME AREA - SEEMED TO STILL COME THROUGH. DECIDED TO CONVERT TO AND AUI. USED A RENU CONVERTER DELIVERED OVER A LUNDERQUIST ON THE RIGHT SIDE AND DEPLOYED JUST INTO THE LIMB OF THE EXISTING GRAFT. THEN PLACED AN OCCLUDER ON THE LEFT SIDE OVER A LUNDERQUIST WIRE. BALLOONED WITH ANOTHER MFR'S BALLOON AND DID A F/U RUN FROM ABOVE AND BELOW FROM THE SHEATH. NO LEAK NOTED ANYWHERE AND GOOD FLOW THROUGH. NO OFF LABEL USE AND I WAS THERE. OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323687 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH, SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 3530623

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention