BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 1020350 · Received March 27, 2008

    Report

    Report Number
    1820334-2008-00156
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: COOK'S INSTRUCTIONS FOR USE DOES INDICATE THAT LONG-TERM PERFORMANCE OF ENDOVASCULAR GRAFTS HAS NOT YET BEEN ESTABLISHED. ALL PTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFE-LONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ADD'L FOLLOW-UP. AFTER ENDOVASCULAR GRAFT PLACEMENT, PTS SHOULD BE REGULARLY MONITORED FOR PERIGRAFT FLOW, ANEURYSM GROWTH OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT. AT A MINIMUM, ANNUAL IMAGING IS REQUIRED INCLUDING: ABDOMINAL RADIOGRAPHS TO EXAMINE DEVICE INTEGRITY AS WELL AS CONTRAST AND NON-CONTRAST CT TO EXAMINE ANEURYSM CHANGES, PERIGRAFT FLOW, PATENCY, TORTUOSITY, AND PROGRESSIVE DISEASE, IF RENAL COMPLICATION OR OTHER FACTORS PRECLUDE THE USE OF IMAGE CONTRAST MEDIA, ABDOMINAL RADIOGRAPHS AND DUPLEX ULTRASOUND MAY PROVIDE SIMILAR INFO. NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THE EVENT WAS CAUSED BY ANATOMICAL CHANGES OVER TIME AND MIGRATION.

    Description of Event or Problem · 1

    A MALE PT INITIALLY UNDERWENT AAA REPAIR IN 2005 WITH A SECONDARY INTERVENTION IN 2007 DUE TO A TYPE III ENDOLEAK. REFER TO 1820334-2007-00224 IN 2008, THE PT CAME IN TO ED WITH SIGNIFICANT BACK PAIN. CTA WAS DONE REVEALING A POSSIBLE TYPE I ENDOLEAK. THE PT WAS BROUGHT TO THE OR, ANGIO WAS PERFORMED AND CONFIRMED AN ENDOLEAK FROM THE RIGHT ILIAC. THE ORIGINAL IPSILATERAL LEG GRAFT WAS NO LONGER MAINTAINING A SEAL AND THE ENDOLEAK WAS FILLING THE ANEURYSM. THE PHYSICIAN DECIDED TO ADD A LEG EXTENSION AND SEAL THE HYPOGASTRIC ON THE RIGHT EVEN THOUGH THE PREVIOUS REPAIR WAS AN EXTENSION SEALING THE LEFT HYPOGASTRIC. A 122MM LENGTH ILIAC LEG GRAFT WAS PLACED AND LANDED IN THE RIGHT EXTERNAL. ON A COMPLETION RUN THERE WAS STILL A LEAK AT THE DISTAL PORTION OF THE ORIGINAL LEG EXTENSION FILLING THE SAME AREA. THE PHYSICIAN BALLOONED AND THE LEAK WAS STILL PRESENT. ALSO, REBALLOONED THE EXTENSION PIECE WITH A 32MM CODA BALLOON AND THERE WAS STILL AN ENDOLEAK. THE PHYSICIAN THOUGHT THERE MAY HAVE BEEN A GRAFT TEAR. THEN, HE LINED THE ILIAC LEG GRAFT WITH ANOTHER ILIAC LEG GRAFT, LANDING IT CLOSE TO THE FLOW DIVIDER PROXIMALLY AND INTO THE EXTERNAL WITHIN THE 122MM GRAFT. THE NEXT RUN STILL REVEALED A LEAK SO BALLOONED WITH A 12X6 BALLOON AND THERE WAS NO LEAK IN THE FINAL RUN. THE PT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA 1977407

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention