BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2090907 · Received May 12, 2011

    Report

    Report Number
    1820334-2011-00226
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 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

    (B)(4) ADDITIONAL SURGICAL PROCEDURE IS NOT SPECIFICALLY ADDRESSED IN THE IFU. (B)(4) MIGRATION IS ADDRESSED IN THE IFU. 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, FOLLOW-UP GUIDELINES. INITIAL REPAIR WAS PERFORMED ON (B)(6) 2009. FOLLOW-UP PERFORMED ON (B)(6) 2011 SHOWED THAT THE CONTRALATERAL (RIGHT) ILIAC LEG MIGRATED. BY REPORT, THE SEALING STENT OF THE COMPLAINT DEVICE WAS "NOT FULLY PLACED" IN THE RIGHT COMMON ILIAC AT THE 1 MONTH FOLLOW-UP. THE CAUSE OF INSUFFICIENT SEALING IS UNK. PT ANATOMY OR A PLANNING AND SIZING ISSUE ARE POSSIBLE CONTRIBUTING FACTORS. ANOTHER MANUFACTURER'S STENT GRAFT WAS EXTENDED INTO THE EXTERNAL ILIAC TO ESTABLISH THE DISTAL SEAL. 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). THIS RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AN (B)(6) MALE PT UNDERWENT INITIAL AAA REPAIR ON (B)(6) 2009. HE HAD SECOND REPAIR ON (B)(6) 2011 BECAUSE A FOLLOW-UP CT TAKEN IN EARLY (B)(6) 2011 SHOWED THAT THE CONTRALATERAL (RIGHT) ILIAC LEG MIGRATED. THE FINAL CONFIRMATORY ANGIOGRAPHY AT THE INITIAL REPAIR SHOWED NO PROBLEM, AND THE PT'S ANATOMICAL FORM SEEMED TO BE SUITABLE FOR THE INITIAL REPAIR ALTHOUGH HIS STATUS AT THAT TIME WAS NOT CONFIRMED BEFORE THE SECOND REPAIR. TO RESOLVE THE MIGRATION, ANOTHER MANUFACTURER'S 12MM X 14CM ENDOPROSTHESIS WAS ADDITIONALLY PLACED TO THE ORIGINAL RIGHT ILIAC LEG TO REACH THE EIA. ALSO, ANOTHER MANUFACTURER'S (23MM X 3.3CM) AORTIC CUFF WAS ADDITIONALLY PLACED TO AVOID THE SAME THING FROM OCCURRING TO THE LEFT ILIAC LEG. THE OPERATION WAS COMPLETED SUCCESSFULLY. THERE HAS BEEN NO PT OUTCOME PROVIDED AFTER THE OPERATION AND NO IMAGES ARE AVAILABLE.

    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 F2302038

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention