BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2140323 · Received June 16, 2011

    Report

    Report Number
    1820334-2011-00307
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 23, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOTENSION - LABELED IN THE IFU. ENDOLEAKS - 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) 2009. FOLLOW-UP CT (B)(6) 2011 REVEALED ANEURYSM EXPANSION WITH NO ENDOLEAK, POSSIBLY ENDOTENSION. PHYSICIAN IS CONSIDERING INTERVENTION. 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 PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2009. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE ENDOVASCULAR REPAIR, AND THE PROCEDURE WAS CONDUCTED AS LABELED. THE FINAL CONFIRMATORY ANGIOGRAPHY DID NOT CONFIRM ANY ENDOLEAK, SO THE PROCEDURE WAS COMPLETED. ON (B)(6) 2011, FOLLOW-UP CT AFTER THE PRIMARY PROCEDURE CONFIRMED ANEURYSM EXPANSION ALTHOUGH NO ENDOLEAK WAS FOUND. THERE HAS BEEN NO PATIENT OUTCOME PROVIDED AND NO IMAGES AVAILABLE. THE PHYSICIAN THINKS THIS MAY BE A TYPE V ENDOLEAK. ADDITIONAL TREATMENT IS BEING CONSIDERED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2288038

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other