BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 3012506 · Received February 20, 2013

    Report

    Report Number
    1820334-2013-00092
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 2, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONVERSION TO OPEN SURGICAL REPAIR IS LABELED IN THE IFU. DIFFICULTY IN PLACING DEVICE IS ADDRESSED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    STENT GRAFT PLACEMENT WAS CONDUCTED TO A (B)(6) MALE PT WITH RIGHT APPROACH AS AN EMERGENCY PROCEDURE DUE TO RAPTURE OF ABDOMINAL AORTA ON (B)(6) 2013. THE PT WAS SUITABLE FOR ENDOVASCULAR REPAIR THOUGH THERE WAS SEVERE TORTUOSITY AND CALCIFICATION IN THE ACCESS ROUTE AND THE PROCEDURE WAS CONDUCTED AS LABELED. THE DELIVERY SYSTEM OF THE DEVICE DID NOT ADVANCE AT ALL WITH RIGHT APPROACH WITH ULTRA STIFF WIRE GUIDE FIRST. THEN, WIRE GUIDE WAS CHANGED TO LUNDERQUIST AND ADVANCEMENT WAS ATTEMPTED AGAIN WITH SOME FORCE TO PUSH IT. THE DELIVERY SYSTEM COULD ADVANCE SOME, BUT COULD NOT REACH TO THE DESIRED POSITION. THEN APPROACHING SITE WAS CHANGED TO THE LEFT AND ADVANCEMENT OF THE DELIVERY SYSTEM WAS PERFORMED WITH ULTRA STIFF WIRE GUIDE FIRST, BUT BECAUSE IT FAILED, THE WIRE GUIDE WAS CHANGED TO LUNDERQUIST. HOWEVER, IT STUCK AGAIN BEFORE REACHING TO THE DESIRED POSITION AND IT BECAME UNABLE FOR THE PHYSICIAN TO ADVANCE OR REMOVE THE DELIVERY SYSTEM. STENT GRAFT PLACEMENT WAS ABANDONED AND THE PHYSICIAN DECIDED TO CONDUCT AN OPEN SURGERY INSTEAD. AFTER THAT, THE DELIVERY SYSTEM COULD BE REMOVED BY PULLING IT. THERE HAS BEEN NO ADVERSE EFFECTS TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74799 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 3077987

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR