BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1582903 · Received January 18, 2010

    Report

    Report Number
    1820334-2010-00027
    Event Type
    Other
    Date Received
    January 18, 2010
    Date of Event
    December 25, 2009
    Report Date
    December 25, 2009
    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

    (B)(4). THE ZENITH DEVICE HAS COMPLETED 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 INSTRUCTIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO ENDOLEAKS AND DEPLOYMENT, 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, THE IMPORTANCE OF AN ACCURATE DEPLOYMENT. THE COMPLAINT CORRESPONDENCE INDICATES THAT THE PHYSICIAN IMPLANTED THE MAIN BODY LOWER THAN EXPECTED. CONTRIBUTING FACTORS OF THE INACCURATE DEPLOYMENT WERE NOT REPORTED. THIS AFFECTED THE LENGTH OF DISTAL SEALING SITE. THE PHYSICIAN REPORTED OVERLAPPING THE DISTAL SEALING STENT IN THE IPSILATERAL MAIN BODY LIMB. THE PHYSICIAN ALSO REPORTED THAT THE DISTAL SEALING SITE WAS LESS THAN 1 STENT. THE ACTUAL DIAMETER IS UNKNOWN. WITH THE INFORMATION PROVIDED, POSSIBLE CONTRIBUTING FACTORS OF THE ENDOLEAK ARE THE INACCURATE DEPLOYMENT OF THE MAIN BODY AND/OR INSUFFICIENT DISTAL SEALING SITE LENGTH (<10MM). THE ASSIGNED FAILURE MODEL IS INACCURATE DEPLOYMENT BASED ON THE COMPLAINT CORRESPONDENCE. WITHOUT IMAGES WE ARE UNABLE TO COMMENT ON THE PATIENT'S SUITABILITY FOR EVAR. WE WILL NOTIFY THE APPROPRIATE PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED AND NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2009. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR AAA REPAIR. WHEN DEPLOYING A MAIN BODY GRAFT, THE SUPRARENAL STENT WAS DEPLOYED BEFORE CONTRALATERAL ILIAC WIRE GUIDE PLACEMENT. LEFT INTERNAL ILIAC ARTERY WAS OCCLUDED AND A CONTRALATERAL (LEFT) ILIAC LEG WAS DEPLOYED INTO THE LEFT EXTERNAL ILIAC ARTERY. ALL OTHER PROCEDURES WERE CONDUCTED AS LABELED. FINAL ANGIOGRAPHY REVEALED A DISTAL TYPE I ENDOLEAK FROM THE IPSILATERAL (RIGHT) ILIAC LEG. THE PHYSICIAN ASSUMED A ENDOLEAK WOULD BE RESOLVED OVER TIME AND DECIDED TO TAKE A WAIT-AND-SEE APPROACH. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL PROCEDURE. THE PATIENT OUTCOME IS UNKNOWN AS NOT PROVIDED BY REPORTER.

    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 F2437460

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other