BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1882555 · Received October 22, 2010

    Report

    Report Number
    1820334-2010-00536
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    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

    PATIENT CODE- PATIENT OUTCOME WAS NOT PROVIDED BY REPORTER. DEVICE CODE- COMPONENT MIGRATION IS LABELED IN THE IFU. THIS PRODUCT LINE HAS ADDRESSED ALL DESIGN CONTROL REQUIREMENTS AND SHOWN THE DEVICE HAS MET THE PREDETERMINED REQUIREMENTS AND THAT THOSE REQUIREMENTS MEET THE NEEDS OF THE END USER. EACH DEVICE IS SENT WITH AN IFU, WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE, THE IFU EMPHASIZES THAT: "AFTER ENDOVASCULAR GRAFT PLACEMENT, PATIENTS 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 (SEPARATION BETWEEN COMPONENTS, STENT FRACTURE OR BARB SEPARATION) AND CONTRAST AND NONCONTRAST CT TO EXAMINE ANEURYSM CHANGES, PERIGRAFT FLOW, PATENCY, TORTUOSITY AND PROGRESSIVE DISEASE..." THE FAILURE MODE ASSIGNED TO THIS CASE IS "ENDOLEAK." THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION AS WELL AS REVIEWING PROVIDED IMAGES FROM THE CUSTOMER. A REVIEW OF THE PREOPERATIVE IMAGES REVEALED THAT THE PATIENT'S RIGHT ILIAC ARTERY APPEARED TO BE TORTUOUS PRIOR TO THE ORIGINAL PROCEDURE, AND IT IS LIKELY THAT THE TORTUOSITY OF THE PATIENT'S ANATOMY OR CHANGES IN THE PATIENT'S ANATOMY LEAD TO THE SEPARATION OF THE TWO GRAFTS. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME. THE RISK IS ACCEPTABLE.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT AN ADDITIONAL EVAR PROCEDURE ON (B)(6) 2010. THE PATIENT HAD RECEIVED A ZENITH MAIN BODY WITH ILIAC LIMBS AND OVER TIME ONE OF THE LIMBS SEPARATED CAUSING A TYPE I ENDOLEAK. THE SEPARATION OCCURRED ON THE RIGHT AT THE GRAFT TO LIMB OVERLAP. THE AREA REPRESENTATIVE STATED THAT IT APPEARED THAT THE TORTUOSITY CAUSED THE GRAFT TO PULL BACK LEADING TO THE SEPARATION. TWO ZENITH ILIAC LEG GRAFTS WERE PLACED BEFORE THE INTERNAL ILIAC TO FORM THE LIMB AND SEAL OFF THE ENDOLEAK. THE SECONDARY PROCEDURE SUCCESSFULLY SEALED THE "GAP" AND THE ENDOLEAK WAS NO LONGER PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention