BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2771919 · Received September 28, 2012

    Report

    Report Number
    1820334-2012-00446
    Event Type
    Injury
    Date Received
    September 28, 2012
    Date of Event
    September 2, 2012
    Report Date
    September 5, 2012
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - RUPTURES ARE LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR ON (B)(6) 2009. DURING THIS INITIAL PROCEDURE DILATORS WERE USED BUT THE PROCEDURE WENT WELL WITH NO PROBLEMS. ON (B)(6) 2012, THE PT WAS TAKEN TO THE EMERGENCY ROOM AND SEEN BY A SURGEON. THE PT HAD A RUPTURED AAA AND BROUGHT IMMEDIATELY TO THE OPERATING ROOM. INITIALLY PLACED AN OCCLUSION BALLOON INTO THE AORTA FOR CONTROL. ACCESSED WITH A 5FR SHEATH THEN TO A 12FR AND PLACED ANOTHER MFR'S BALLOON. THE PHYSICIAN DID A MIDLINE INCISION AND FOUND THAT THE AORTA WAS RUPTURED ANTERIORLY. THE PHYSICIAN HAD CONTROL WHILE THE BALLOON WAS UP. THE GRAFT WAS CUT OUT AND LEFT ONLY THE SUPRA RENAL STENT. SCISSORS AND WIRE CUTTERS WERE USED TO TAKE OUT THE GRAFT. THE PT HAD NUMEROUS LUMBARS THAT THE PHYSICIAN SUTURED. THEN PLACED AX-BY-FEM GRAFT. THE PHYSICIAN ATTACHED DOWN TO BOTH FEMORALS. THE PT WAS THEN TRANSFERRED TO SICU, SURGERY INTENSIVE CARE UNIT, IN CRITICAL CONDITION. PT STILL ALIVE, LONG PROCEDURE AND MASSIVE BLOOD LOSS. PT WAS ALSO SENT AWHILE BACK TO ANOTHER FACILITY TO TREAT A TYPE II LEAK AND THAT WAS COILED AND GLUED BY A PHYSICIAN. PT SEEMS TO HAVE BEEN LOST TO F/U SINCE. IT IS UNK IF PT WAS BEING SEEN AT THAT FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA 2400403

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention