BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH RENU AAA ANCILLARY GRAFT

    MDR report key: 1062598 · Received June 18, 2008

    Report

    Report Number
    1820334-2008-00300
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IN 2008, THE PHYSICIAN ATTEMPTED TO USE A RENU CONVERTER TO REPAIR ANOTHER MANUFACTURER'S MIGRATED GRAFT. THE MALE PATIENT'S ANATOMY WAS EXTREMELY TORTUOUS. INITIAL INSERTION OF THE DEVICE PRESENTED TRACKABILITY ISSUES. IN ORDER TO GET AROUND THE TORTUOUS ILIACS, THE PHYSICIAN HAD HIS PARTNER PLACE PRESSURE ON THE ABDOMEN TO ADVANCE THE DEVICE TO THE PROPER POSITION. THE SAME PROBLEM OCCURRED WHEN TRYING TO DOCK THE TOP CAP. THE GRAY POSITIONER WOULD NOT EASILY ADVANCE. ALL OTHER STEPS WERE COMPLETED PROPERLY (TRIGGER WIRES RELEASED, PIN VISE LOOSENED AND TIGHTENED, ETC.). THE STENT GRAFT MIGRATED PROXIMALLY AND COVERED THE RENALS. ATTEMPTS TO PULL THE GRAFT DOWN WITH A 14X4 BALLOON WERE MADE. THIS WAS EVENTUALLY ABORTED TO AVOID CAUSING TRAUMA TO THE ARTERY. THE PATIENT WAS OPENED AND THE DEVICE WAS EXPLANTED. PATIENT WAS STABLE THROUGHOUT PROCEDURE AND PATENT FLOW AT THE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH RENU AAA ANCILLARY GRAFT MIH SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC. NA 1904890

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention