BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2081506 · Received April 26, 2011

    Report

    Report Number
    1820334-2011-00222
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 7, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVAL: STILL UNDER INVESTIGATION AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) MALE PT RECEIVED A ZENITH MAIN BODY GRAFT AND TWO ZENITH ILIAC LEGS ON (B)(6) 2007. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INCIDENT; HOWEVER, DURING THE ORIGINAL IMPLANT, THE PHYSICIAN DISCOVERED THE PT'S ANATOMY CONTAINED AN ANGULATED NECK. THE OUTCOME OF THE ORIGINAL REPAIR WAS A TYPE I ENDOLEAK PROXIMAL. ANOTHER MFR'S STENT WAS PLACED TO CORRECT THE TYPE I ENDOLEAK DUE TO THE FACT THE GRAFT WAS AT THE RENAL BUT NOT OPPOSING THE WALLS OF THE VESSEL WELL. (1820334-2011-00236). OVER TIME, THE PT DEVELOPED A TYPE III ENDOLEAK WITH COMPLETE SEPARATION OF BOTH ILIAC LIMBS. ON (B)(6) 2011, THE PT UNDERWENT A SECONDARY PROCEDURE TO RESOLVE THE ENDOLEAK. THE PHYSICIAN RESOLVED THE LEAK WITH PLACEMENT OF ZENITH ILIAC LEG GRAFTS, ON BOTH SIDES, TO RECONNECT THE LIMBS TO THE ZENITH MAIN BODY GRAFT. THE PHYSICIAN RESOLVED THE LEAK WITH PLACEMENT OF ZENITH ILIAC LEG GRAFTS, ON BOTH SIDES, TO RECONNECT THE LIMBS TO THE ZENITH MAIN BODY GRAFT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention