BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2111133 · Received May 25, 2011

    Report

    Report Number
    1820334-2011-00275
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 11, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ADDRESSED IN THE IFU. (B)(4) - OCCLUSION IS ADDRESSED 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 USER. EACH DEVICE IS SENT WITH AN IFU WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, SIZING INSTRUCTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE, THE IFU STATES: "INABILITY TO MAINTAIN PATENCY OF AT LEAST ONE INTERNAL ILIAC ARTERY OR OCCLUSION OF AN INDISPENSABLE INFERIOR MESENTERIC ARTERY MAY INCREASE THE RISK OF PELVIC/BOWEL ISCHEMIA." THE FAILURE MODE ASSIGNED TO THIS CASE IS INACCURATE DEPLOYMENT. THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION AS WELL AS THE PHYSICIANS' COMMENTS: "IT WAS CAUSED BY A MEASUREMENT ERROR. IT SEEMS THAT ANGLES OF X-RAY WERE NOT ACCURATE ENOUGH." NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME. THE RISK IS INSUFFICIENT PER QUALITY ENGINEERING RISK ASSESSMENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE ENDOVASCULAR REPAIR AND THE PROCEDURE WAS CONDUCTED AS LABELED. (DIAMETER OF THE ANEURYSM: 41MM, DIAMETER OF CIA: 18MM, DIAMETER OF THE ACCESS ROUTE: 8.5MM). THE PHYSICIAN CONFIRMED THAT A LEFT ILIAC LEG OCCLUDED A LEFT IIA DURING THE IMPLANTATION PROCEDURE OF THE LEFT ILIAC LEG. HE ATTEMPTED TO PUSH UP THE LEG WITH THE DELIVERY SHEATH, BUT FAILED. THE LOCATION OF THE PLACED LEFT ILIAC LEG COULD NOT BE MODIFIED. THERE HAVE BEEN NO PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2587958

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR