BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2132181 · Received June 14, 2011

    Report

    Report Number
    1820334-2011-00287
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 16, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT OUTCOME WAS NOT PROVIDED BY REPORTER. ENDOLEAKS ARE 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, F/U GUIDELINES. BY REPORT, OFF LABEL USE DUE TO ANATOMICAL EXCLUSION (SHORT INFRARENAL NECK). PRIMARY TYPE 1A REDUCED AFTER PLACEMENT OF ANOTHER MFR'S STENT. PHYSICIAN DECIDED TO TAKE WAIT-AND-SEE APPROACH. PT ANATOMY LIKELY CONTRIBUTED TO THE REPORTED ENDOLEAK. 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

    AN (B)(6) FEMALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS NOT SUITABLE FOR ENDOVASCULAR REPAIR. (PROXIMAL NECK LENGTH: 13MM - 15MM, NO PROBLEM IN ACCESS ROUTE.) THE PROCEDURE WAS CONDUCTED UNDER GENERAL ANESTHESIA. THE FINAL CONFIRMATORY ANGIOGRAPHY SHOWED A PROXIMAL TYPE I ENDOLEAK. OTHER MFR'S STENT AND BALLOON WERE USED FOR SEALING AT THE PROXIMAL SITE. THEN, THE ENDOLEAK WAS REDUCED AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH. THERE HAS BEEN NO PT'S OUTCOME REPORTED AND NO IMAGES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2603964

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention