BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2162144 · Received July 7, 2011

    Report

    Report Number
    1820334-2011-00367
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 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) PATIENT CONDITION WAS NOT PROVIDED BY REPORTER. (B)(4) 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, FOLLOW-UP GUIDELINES. FINAL ANGIOGRAPHY REVEALED A TYPE IA ENDOLEAK. BALLOONING REDUCED THE ENDOLEAK, BUT IT REMAINED. IT WAS THOUGHT THAT PLACEMENT OF ANOTHER MANUFACTURER'S STENT RESOLVED THE ENDOLEAK. THE SALES REPRESENTATIVE CONTRIBUTED THE TYPE IA ENDOLEAK TO NECK ANGULATION AND INVERTED FUNNEL SHAPE. AT THIS TIME THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTED IN 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

    ON (B)(6) 2011, AN (B)(6) MALE PATIENT UNDERWENT AAA REPAIR. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED PRELIMINARILY. THE FINAL CONFIRMATORY ANGIOGRAPHY SHOWED A PROXIMAL TYPE I ENDOLEAK AND A TYPE IV ENDOLEAK FROM THE LEFT LEG (1820334-2011-00368). THE PHYSICIAN BALLOONED ADDITIONALLY USING A CODA BALLOON FOR THE TYPE I, BUT IT STILL REMAINED. IT WAS MOSTLY GONE AFTER PLACEMENT OF ANOTHER MANUFACTURER'S STENT. THE TYPE IV WAS SLIGHTLY PERSISTED EVEN AFTER PLACEMENT OF ANOTHER ILIAC LEG GRAFT. HOWEVER THE PHYSICIAN DECIDED TO TAKE A WAIT AND SEE APPROACH AND COMPLETED THE PROCEDURE. THE PATIENT'S CONDITION IS UNKNOWN AS NOT PROVIDED BY REPORTER AND NO IMAGES WILL BE PROVIDED TO ASSIST IN THIS INVESTIGATION.

    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 F2627487

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention