BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2120291 · Received June 1, 2011

    Report

    Report Number
    1820334-2011-00272
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ADDITIONAL PROCEDURES ARE NOT SPECIFICALLY LABELED IN THE IFU. (B)(4) ENDOLEAKS ARE NOT LABELED IN THE IFU. 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. INITIAL REPAIR PERFORMED ON (B)(6) 2010. FOLLOW UP CT REVEALED A TYPE IB ENDOLEAK AND AN ADDITIONAL ZENITH ILIAC LEG WAS PLACED TO RESOLVE. WITHOUT ADDITIONAL INFO OR IMAGING, WE ARE UNABLE TO DETERMINE CONTRIBUTING FACTORS OR HOW THE DEVICE CONTRIBUTED TO THE EVENT. 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) MALE PT UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2010. THE PT RECEIVED A ZENITH BIFURCATED MAIN BODY AND TWO ZENITH ILIAC LIMB GRAFTS. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INCIDENT. AFTER FOLLOW UP CT'S, IT WAS FOUND THAT THERE WAS A SMALL TYPE I DISTAL ENDOLEAK. IT DID NOT GO INTO THE SAC. IT ONLY WENT ALONG THE SIDE OF THE EXISTING LIMB ABOUT 2 CENTIMETERS. THE PT HAD NO SYMPTOMS OR COMPLAINTS. ON (B)(6) 2011, THE PT UNDERWENT A SECONDARY PROCEDURE WHERE THE PHYSICIAN IMPLANTED A ZENITH ANCILLARY ILIAC GRAFT TO EXTEND DOWN ON THE DISTAL END OF THE LEFT LIMB. PHYSICIAN WAS ABLE TO SEAL RIGHT AT THE INTERNAL ILIAC. FINAL RUN WAS DONE AND SHOWED NO ENDOLEAK. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    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 2435420

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention