BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2011668 · Received March 3, 2011

    Report

    Report Number
    1820334-2011-00111
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 4, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOLEAKS ARE LABELED IN THE IFU. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION. THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO ENDOLEAKS, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS; ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, PROPER BALLOONING SITES, F/U GUIDELINES. THE FAILURE MODE ASSIGNED TO THIS CASE IS ENDOLEAK, THIS WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION. THE ENDOLEAK WAS TREATED WITH PLACEMENT OF AN ADDITIONAL DEVICE. AS WITH ALL ENDOLEAKS, IT IS IMPORTANT THAT THE TREATING PHYSICIAN FOLLOW THE PT'S ENDOLEAK APPROPRIATELY, AND PROVIDE FURTHER TREATMENT IF THE PHYSICIAN FEELS THE PT IS AT RISK OF ONGOING SAC PRESSURIZATION, ANEURYSM GROWTH, AND POSSIBLE RUPTURE. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME. THE RISKS REMAIN AT ACCEPTABLE LEVELS.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE AND THE PROCEDURE WAS CONDUCTED AS LABELED. AFTER PLACEMENT OF GRAFTS, AN ENDOLEAK (THOUGHT TO BE TYPE III) WAS OBSERVED FROM THE JUNCTION PART OF THE RIGHT ILIAC LEG BY THE FINAL ANGIOGRAPHY. BALLOONING WAS PERFORMED AT THE JUNCTION PART AND DISTAL SITE OF THE RIGHT ILIAC LEG, BUT ANGIOGRAPHY STILL REVEALED TYPE III ENDOLEAK FROM THE JUNCTION REMAINED. THEN ADDITIONAL ILIAC LEG WAS PLACED A LITTLE BIT LOWER POSITION THAN THAT THE INITIAL RIGHT ILIAC LEG WAS PLACED. IT WAS CONFIRMED TYPE III ENDOLEAK WAS RESOLVED. THE PT'S CONDITION IS UNK AS NOT PROVIDED BY REPORTER.

    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 F2536507

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention