BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2504761 · Received January 23, 2012

    Report

    Report Number
    1820334-2012-00164
    Event Type
    Injury
    Date Received
    January 23, 2012
    Date of Event
    September 15, 2011
    Report Date
    February 27, 2012
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A (B)(6) MALE WITH ENDOLEAK TYPE 2 WITH AUGMENTATION OF ANEURYSM ISCHEMIA OF THE RIGHT SIDE WITH THROMBUS ON THE RIGHT SIDE IN (B)(6) 2011, RETROPERITONEAL HEMATOMA IN (B)(6) 2011 UNDERWENT EVAR ON (B)(6) 2011. THE PT CARRYING AN ENDOSTENT WITH A TINY LEAK (1820344-2012-00164) IN IT BUT KNOWN ISSUE AND FOLLOW UP ON THAT REGULARLY. DECISION TAKEN OF AN EMBOLIZATION OF THIS LEAK. DURING THE PROCEDURE. HOSPITAL NOTICED AN AORTOILIAC THROMBOSIS (1820334-2012-00166). HOSPITAL HAD TO PERFORM A BRIDGING. THE PT STAYED 3 WEEKS IN CRITICAL CARE. UPDATE FROM COMPLAINT FORM RECEIVED (B)(4) 2012: THE EMBOLIZATION OF ENDOLEAK WAS PERFORMED UNDER GENERAL ANESTHESIA, WITH PT IN PRONE POSITION AND PERCUTANEOUS TRANSLUMBAR APPROACH. AT THE END OF THE PROCEDURE THE PT PRESENTED WITH ISCHEMIA OF BOTH LEGS, WITH AORTOILIAC THROMBOSIS CONFIRMED BY DOPPLER. THE PT HAS BEEN TRANSFERRED TO SURGICAL SUITE AND AFTER UNSUCCESSFUL THROMBECTOMY, AN AXILLOFEMORAL BYPASS WAS PERFORMED. ADDITIONAL INFO RECEIVED (B)(4) 2012: IN RESPONSE TO WHEN THE ISCHEMIA OCCURRED "IT OCCURRED DURING EMBOLIZATION OF ENDOLEAK TYPE 2."

    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 2427223

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention