BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH RENU CONVERTER AAA ANCILLARY GRAFT

    MDR report key: 1033866 · Received April 25, 2008

    Report

    Report Number
    1820334-2008-00225
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    October 17, 2005
    Report Date
    March 28, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: COOK'S INSTRUCTIONS FOR USE DOES ADVISE THAT AFTER SECONDARY ENDOVASCULAR INTERVENTION, PTS SHOULD BE REGULARLY MONITORED FOR PERIGRAFT FLOW, ANEURYSM GROWTH OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT. AT A MINIMUM IMAGING SHOULD INCLUDE ABDOMINAL RADIOGRAPHS TO EXAMINE INTEGRITY, CONTRAST AND NON-CONTRAST CT TO EXAMINE ANEURYSM CHANGES, PERIGRAFT FLOW, PATENCY, TORTUOSITY AND DISEASE PROGRESSION. ONLY PT WITH RENAL COMPLICATIONS OR OTHER FACTORS PRECLUDING THE USE OF IMAGE CONTRAST MEDIA SHOULD BE MONITORED USING NON-CONTRAST CT AND DUPLEX ULTRASOUND. THE DEVICE REMAINS IMPLANTED AND NO IMAGES WERE PROVIDED TO ASSIST WITH THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THA THE EVENT WAS CAUSED BY PT ANATOMY.

    Description of Event or Problem · 1

    A MALE HAD UNDERGONE INITIAL AAA REPAIR WITH ANOTHER MFR'S GRAFT 85 MONTHS PRIOR TO ZENITH PLACEMENT. THE PRE-EXISTING CUSTOM GRAFT HAD DEVELOPED AN ENDOLEAK AND KINK, RESULTING IN A TYPE I ENDOLEAK. A RENU CONVERTER WAS PLACED IN 2005, AND AT THAT TIME NO ENDOLEAK WAS NOTED. HOWEVER, CORE LAB REVIEW OF THE PROCEDURAL COMPLETION ANGIOGRAM INDICATES A PROXIMAL TYPE I ENDOLEAK. CORE LAB REVIEW OF 30-DAY F/U REPORTED NO ENDOLEAK. THE 6 AND 12-MONTH FOLLOW-UPS WERE REVIEWED BY CORE LAB AND INDICATE A TYPE II ENDOLEAK HAS DEVELOPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH RENU CONVERTER AAA ANCILLARY GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA 1549790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention