BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION

    MDR report key: 2140345 · Received June 16, 2011

    Report

    Report Number
    1820334-2011-00335
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION AT THIS TIME. 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, PATIENT ANATOMY LIKELY CONTRIBUTED TO THE REPORTED TYPE 1A. A ZENITH RENU CUFF WAS PLACED TO RESOLVE, BUT THE CUFF MIGRATED UPWARDS AND COVERED BOTH RENAL ARTERIES. HOWEVER, BLOOD FLOW WAS CONFIRMED AND THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH WHILE THE PHYSICIAN DETERMINES THE APPROPRIATE COURSE OF ACTION. CAUSE OF THE MIGRATION IS UNKNOWN WITHOUT ADDITIONAL INFORMATION OR IMAGING. IT IS POSSIBLE THAT PATIENT ANATOMY WAS A CONTRIBUTING FACTOR. 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) AND THE 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

    A (B)(6) FEMALE PATIENT WITH A VERY CHALLENGING ANATOMY, UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR (B)(6) 2011. THE PHYSICIAN PLACED A ZENITH MAIN BODY AND TWO ZENITH ILIAC LEG GRAFTS. PATIENT HAD A VERY ANGULATED NECK WHICH MAY HAVE LEAD TO THE TYPE I ENDOLEAK THAT DEVELOPED. PHYSICIAN CHOSE TO PLACE A ZENITH RENU CUFF TO SEAL OFF THE LEAK. HOWEVER, THE RENU MIGRATED UPWARDS AND COVERED BOTH RENAL ARTERIES. PATIENT STILL HAD FLOW TO THE RENALS AND IT DID APPEAR TO SEAL BELOW RENALS WITH THE RENU. PHYSICIAN WILL BE MONITORING THE PATIENT AND PLANNING A SECONDARY PROCEDURE. PATIENT WAS PUT ON MEDICATION TO TRY AND KEEP FLOW TO RENALS TILL FURTHER OPTIONS CAN BE EXPLORED. THE COOK SALES REP IS ATTEMPTING TO OBTAIN IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2562824

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability