BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2000515 · Received February 1, 2011

    Report

    Report Number
    1820334-2011-00055
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 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

    ENDOLEAKS ARE ADDRESSED PER THE PROVIDED 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. WITHOUT ADD'L INFO OR IMAGING WE ARE UNABLE TO COMMENT ON THE PT'S SUITABILITY FOR EVAR OR POSSIBLE CONTRIBUTING FACTORS. THE SALES REP INDICATED THAT THE LENGTH OF THE SEALING SITE AND CALCIFICATION MAY HAVE CONTRIBUTED TO THE REPORTED ENDOLEAK. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH BECAUSE OF THE VESSEL CONDITION. AS WITH ALL ENDOLEAKS, IT IS IMPORTANT THAT THE TREATING PHYSICIAN FOLLOW THE PT'S ENDOLEAK APPROPRIATELY, AND PROVIDE FURTHER TREATMENTS 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. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ASSESSMENT (QERA).

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR. A MAINBODY AND TWO ILIAC LEG GRAFTS WERE PLACED AND THE FINAL ANGIOGRAPHY CONFIRMED A DISTAL TYPE I ENDOLEAK IN THE LEFT COMMON ILIAC ARTERY AND ANOTHER ENDOLEAK. THE PHYSICIAN DETERMINED ANOTHER ENDOLEAK WAS A TYPE II FROM THE LUMBAR ARTERIES AFTER ADD'L BALLOONING. HE DECIDED TO TAKE A WAIT AND SEE APPROACH FOR THE DISTAL TYPE I ENDOLEAK DUE TO THE VESSEL CONDITION. THE SALES REP REPORTED THE SEALING AREA WAS SHORTER AND CALCIFIED SOME. 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 F2564914

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR