BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2071834 · Received April 21, 2011

    Report

    Report Number
    1820334-2011-00186
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 22, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOLEAKS ARE ADDRESSED IN THE PROVIDED IFU. EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE PROCEDURE WAS CONDUCTED AS LABELED. FINAL CONFIRMATORY ANGIOGRAPHY REVEALED AN ENDOLEAK. CT WAS TAKEN FROM FRONT, RIGHT AND LEFT SIDE WITH A C-ARM. THE ENDOLEAK WAS THOUGHT TO BE TYPE III CAUSED DUE TO A PIN HOLE. A MAIN BODY EXTENSION WAS PLACED AT THE SITE ABOVE THE MAIN BODY LIMBS THAT THE TYPE III WAS THOUGHT TO BE CAUSED. THE ENDOLEAK WAS NOT RESOLVED. THEN THE PHYSICIAN CONSIDERED THE ENDOLEAK WAS CAUSED FROM JUNCTION PART OF THE LEFT ILIAC LEG, AND ANOTHER MANUFACTURER'S STENT WAS PLACED TO RESOLVE IT. HOWEVER, THE ENDOLEAK WAS STILL NOT RESOLVED. THE PATIENT'S CONDITION AFTER THE PROCEDURE IS UNKNOWN AS THIS INFORMATION WAS NOT PROVIDED BY THE REPORTER. ACT WAS OVER 200.

    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 F2604481

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention