BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 1372763 · Received April 29, 2009

    Report

    Report Number
    1820334-2009-00259
    Event Type
    Injury
    Date Received
    April 29, 2009
    Date of Event
    February 4, 2009
    Report Date
    April 3, 2009
    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

    EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE WAS CONSIDERED NOT SUITABLE FOR ENDOVASCULAR THERAPY, BUT UNDERWENT ENDOVASCULAR REPAIR WITH ZENITH DEVICES IN 2009. THE PROCEDURE WENT AS LABELED. A MAIN BODY, A LEFT ILIAC LEG, AND CONVERTER WERE DEPLOYED AND FEM-FEM BYPASS WAS PERFORMED. FINAL ANGIOGRAPHY REVEALED A TYPE III ENDOLEAK FROM THE AREA WHERE THE CONVERTER WAS PLACED. THE PHYSICIAN BALLOONED THE LEAKING AREA WITH AN OCCLUSION BALLOON CATHETER, BUT THE ENDOLEAK WAS NOT COMPLETELY RESOLVED. THE PHYSICIAN THEN SUSPECTED THAT THE LEAK WAS DUE TO THE GRAFT ITSELF AND PLACED A MAIN BODY EXTENSION AT THE PROXIMAL PORTION OF THE CONVERTER. THE ENDOLEAK PERSISTED, BUT IT WAS LESSENED AND THE PHYSICIAN THOUGHT IT WOULD RESOLVE AFTER NEUTRALIZATION OF THE HEPARIN. THE PHYSICIAN DECIDED TO WAIT-AND-SEE APPROACH AND COMPLETED THE PROCEDURE. AS AT TIME OF REPORT, CONFIRMATORY ANGIOGRAPHY CT CONFIRMED THE ENDOLEAK WAS RESOLVED. THE PHYSICIAN COMMENTED. "PERFORMING THE FEM-FEM BYPASS WAS NOT PLANNED AT FIRST, BUT THE TORTUOUS OF THE RIGHT ILIAC ARTERY DUE TO SYNECHIA COULD NOT BE STRAIGHTENED, SO THE PHYSICIAN DECIDED TO APPROACH FROM THE LEFT ILIAC ARTERY AND PERFORM THE FEM-FEM BYPASS. THERE IS A POSSIBILITY THAT THE MAIN BODY AND THE CONVERTER WERE NOT SEALED ENOUGH." PT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2238235

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention