BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2090073 · Received May 5, 2011

    Report

    Report Number
    1820334-2011-00227
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 7, 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) ENDOLEAKS ARE LABELED IN THE IFU. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST 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, THE PT WAS NOT SUITABLE FOR EVAR DUE TO ANATOMICAL EXCLUSION (SHORT INFRARENAL NECK AND ANEURYSMAL). THE PHYSICIAN DEPLOYED THE ENDOGRAFT AND COVERED THE LEFT RENAL ARTERY TO TRY AND OBTAIN A SEAL. HOWEVER, A TYPE 1A ENDOLEAK WAS DETECTED AND REDUCED AFTER PLACEMENT OF A MAIN BODY EXTENSION. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH. AT THIS TIME THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTED IN THE REPORTED TYPE 1A ENDOLEAK. AS WITH ALL ENDOLEAKS, IT IS IMPORTANT THAT THE TREATING PHYSICIAN FOLLOW THE PT'S ENDOLEAK APPROPRIATELY, AND PROVIDE FURTHER TREATMENT IF THE PHYSICIAN FEELS THE PT IS AT RISK OF ONGOING SAC PRESSURIZATION, ANEURYSM GROWTH, AND POSSIBLE RUPTURE. 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 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, A (B)(6) MALE PT UNDERWENT AAA REPAIR. THE PT'S ANATOMICAL FORM WAS NOT SUITABLE FOR THE PROCEDURE BECAUSE THE PROXIMAL NECK WAS SHORT AS THE AORTA WAS ANEURYSMAL RIGHT UNDER THE RENAL ARTERIES. THEREFORE THE LEFT RENAL ARTERY HAD TO BE COVERED BY MAINBODY. THE PROCEDURE WAS CONDUCTED AS LABELED AND THE FINAL ANGIOGRAPHY SHOWED PROXIMAL TYPE I ENDOLEAK. IT WAS NOT SOLVED AFTER ADD'L BALLOONING. IT BECOME MUCH BETTER AFTER PLACEMENT OF BODY EXTENSION BUT STILL PERSISTED. THE PHYSICIAN DECIDED TO TAKE A WAIT AND SEE APPROACH. THEN ANGIOGRAPHY SHOWED A LEFT ADRENAL ARTERY WAS STENOSED. THE PHYSICIAN ATTEMPTED TO TREAT THE STENOSIS BUT FOUND ANOTHER ADRENAL ARTERY ABOVE, SO DECIDED TO TAKE A WAIT AND SEE APPROACH. (1820334-2011-00228). THE PT'S CONDITION IS UNK AS NOT PROVIDED BY REPORTER.

    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 F2604455

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention