BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY

    MDR report key: 3935498 · Received June 23, 2014

    Report

    Report Number
    9680654-2014-00011
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    WILLIAM A. COOK AUSTRALIA
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT AN ENDOVASCULAR AORTIC REPAIR PROCEDURE WITH A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY ((B)(4)). DURING THE PROCEDURE IT WA NOTED THE VALVES ON THE SHEATH WERE NOT HEMOSTATIC SO THE PATIENT LOST A CONSIDERATE AMOUNT OF BLOOD (REPORTED SEPARATELY - SEE 9680654 2014 00010). DURING THE SAME PROCEDURE A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BODY ((B)(4)) WAS ALSO USED AND THIS ALSO LEAKED IN THE SAME MANNER. THE GRAFT WAS DEPLOYED AS THE PHYSICIAN INTENDED AND NO ADDITIONAL PROCEDURES WERE NEEDED. THE PATIENT IS DOING WELL POST PROCEDURE. THE PATIENT REQUIRED A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367307 ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY NONE MIH WILLIAM A. COOK AUSTRALIA AC934913

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R