BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1894551 · Received November 5, 2010

    Report

    Report Number
    1820334-2010-00561
    Event Type
    Death
    Date Received
    November 5, 2010
    Date of Event
    September 13, 2010
    Report Date
    October 8, 2010
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEATH AN RENAL FAILURE ARE LABELED IN THE IFU. ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED ON (B)(6) 2010 WITH LARGE ANEURYSM AND EPISODE OF HYPOTENSION IN OUTSIDE FACILITY WHERE HE PRESENTED WITH CHEST PAIN. UNDERWENT EVAR CONVERTED TO AORTO-UNIILIAC WITH RIGHT TO LEFT FEM-FEM BYPASS ON (B)(6) 2010 AMPUTATED. THE PHYSICIAN FEELS THIS EVENT IS NOT DEVICE RELATED. PT HAD A MI POST-OP. DEVELOPED COMPARTMENT SYNDROME IN BOTH LEGS IN THE EARLY MORNING AFTER THE PROCEDURE (CONFIRMED BY COMPARTMENT PRESSURES IN BOTH LEGS, TENSE COMPARTMENTS, HIGH CPK AND MYOGLOBINURIA). PT UNDERWENT FOUR COMPARTMENT FASCIOTOMY ON THE MORNING OF (B)(6) 2010. DEVELOPED RENAL FAILURE. BILATERAL AKA ON (B)(6) 2010 WITH FEM-FEM BYPASS WORKING. THE FAMILY REQUESTED WITHDRAWAL OF CARE SINCE THERE WAS NO IMPROVEMENT. THE PT EXPIRED ON (B)(6) 2010. THE CONVERTER DID NOT REPAIR THE LEAK COMPLETELY. AFTER BEING UNABLE TO CANNULATE THE CONTRALATERAL LIMB, PLACED A CONVERTER BUT HAD PERSISTENT PROXIMAL ENDOLEAK THAT APPEARED TO BE TYPE III (MAIN BODY DEVICE WITH THE CONVERTER-CONTRAST IN THE EXCLUDED LIMB OF THE MAIN BODY DEVICE). THEN PLACED A PROXIMAL CUFF AND LEAK PERSISTED. PLACED THE RENU DEVICE WITH THE PROXIMAL LANDING ZONE JUST BELOW THE RENALS (WE PROBABLY GAIN ANOTHER 3MM FOR THE PROXIMAL LANDING ZONE). LEAK PERSISTED BUT IMPROVED. THEN PERFORMED THE RIGHT TO LEFT FEM-FEM BYPASS AND FINISHED THE CASE TRANSFERRING PT TO ICU. NO KINKS FROM THE RENU DEVICE. FEM-FEM BYPASS REMAINED OPENED. COMPARTMENT SYNDROME PROBABLY RELATED TO THE PROLONGED PROCEDURE WITH HYPOPERFUSION AND THEN REPERFUSION INJURY.

    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 2514301

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| L