BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2082070 · Received April 26, 2011

    Report

    Report Number
    1820334-2011-00211
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 4, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR THE ENDOVASCULAR REPAIR. THE PROCEDURE WAS CONDUCTED AS LABELED. AFTER ALL THE DEVICES WERE PLACED CORRECTLY, BALLOONING WITH CODA WAS PERFORMED BECAUSE A PROXIMAL TYPE I ENDOLEAK WAS SUSPECTED. THE ENDOLEAK WAS NOT RESOLVED WHEN THE CONFIRMATORY ANGIOGRAPHY TAKEN, SO REBALLOONING WITH CODA WAS PERFORMED FOR OCCLUSION JUST BEFORE THE BIFURCATION AREA. ANOTHER ANGIOGRAPHY WAS TAKEN AND SHOWED THAT THE ENDOLEAK REMAINED. THE PHYSICIAN JUDGED IT AS A TYPE IV ENDOLEAK AND DECIDED TO TAKE A WAIT-AND-SEE APPROACH. (ACT: MORE THAN 200). THE PT HAD NO ADVERSE EFFECTS FROM THE PROCEDURE.

    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 F2603903

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR