BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2869453 · Received November 29, 2012

    Report

    Report Number
    1820334-2012-00546
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 21, 2011
    Report Date
    November 8, 2012
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THROMBUS AND OCCLUSION ARE LABELED IN THE IFU. MFR DATE: UNKNOWN AS LOT IS UNKNOWN. EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PER COMPLAINT FORM: THE GRAFT IS STILL IMPLANTED AND THE PATIENT HAS NO ADVERSE SYMPTOMS. HOWEVER, AFTER LOOKING AT THE POST-OP WORK, THE BACK WALL OF THE SUPRARENAL STENT IS NOT LAYING PROPERLY. THERE IS A SMALL PINCH IN THE NATIVE AORTA, AND UNFORTUNATELY THE GRAFTS SITTING POORLY IN IT CAUSING THE POSTERIOR SIDE NOT TO OPPOSE. THERE IS ALSO THROMBUS INSIDE OF THE GRAFT THAT WAS NOT PREVIOUSLY THERE. THE RADIOLOGIST WANTS A SECOND OPINION TO SEE IF ADDITIONAL STENTING WOULD BE ADVANTAGEOUS, OR SINCE THE PATIENT ISN'T EXPERIENCING ANY SYMPTOMS, IF HE SHOULD JUST LEAVE IT ALONE. WE'VE SENT THE SCANS THAT WERE DONE RIGHT AFTER IMPLANT, AND DONE ON (B)(6) 2012. YOU CAN SEE THAT THE GRAFT HAS MIGRATED SLIGHTLY AND THAT THE GRAFT IS MORE CONSTRAINED AT THE SUPRARENAL AREA. YOU CAN ALSO SEE THE THROMBUS FORMING INSIDE THE 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR