BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2082746 · Received April 28, 2011

    Report

    Report Number
    1820334-2011-00212
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONVERSION TO OPEN SURGICAL REPAIR IS LABELED IN THE IFU. DIFFICULTY PLACING DEVICE AND TOP CAP GETTING TANGLED IS NOT SPECIFICALLY LABELED IN THE IFU. CUSTOMER RETURNED TOP HALF OF THE STENT GRAFT. THIS PRODUCT LINE HAS ADDRESSED ALL DESIGN CONTROL REQUIREMENTS AND SHOWN THE DEVICE HAS MET THE PREDETERMINED REQUIREMENTS AND THAT THOSE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH DEVICE IS SENT WITH INSTRUCTIONS FOR USE (IFU) WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, SIZING INSTRUCTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE, THE IFU STATES: "THE ZENITH FLEX AAA ENDOVASCULAR GRAFT INCORPORATES A SUPRARENAL STENT WITH FIXATION BARBS. EXERCISE EXTREME CAUTION WHEN MANIPULATING INTERVENTIONAL DEVICES IN THE REGION OF THE SUPRARENAL STENT." "CARE SHOULD BE TAKEN NOT TO DAMAGE THE GRAFT OR DISTURB GRAFT POSITIONING AFTER GRAFT PLACEMENT IN THE EVENT REINSTRUMENTATION OF THE GRAFT IS NECESSARY." THE RETURNED STENT GRAFT PORTION WAS EXAMINED BY INTERNAL PERSONNEL. THE SUPRARENAL STENT OF THE RETURNED DEVICE APPEARS TO HAVE BEEN SNARED OR CAUGHT ON SOMETHING, AS THE EVENT DESCRIPTION INDICATES. A TEAR WAS ALSO FOUND TO BE PRESENT AT THE APICES OF THE PROXIMAL SEAL STENT, WHICH MAY HAVE BEEN CUT OR TORN DURING THE EXPLANT PROCEDURE, HOWEVER IT IS UNCLEAR HOW THE TEAR OR CUT OCCURRED. THE FAILURE MODE ASSIGNED TO THIS CASE IS GRAFT DEPLOYED INACCURATELY. THIS WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION AS WELL AS EXAMINATION OF THE RETURNED DEVICE. IT APPEARS THAT THE PHYSICIAN DID NOT EXERCISE CAUTION IN THE REGION OF THE SUPRARENAL STENT UPON REMOVAL OF THE SUBASSEMBLY, AS THE IFU PROVIDES WARNINGS AND PRECAUTIONS ABOUT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO FURTHER RISK REDUCTION ACTIVITIES ARE REQUIRED PER QUALITY ENGINEERING RISK ANALYSIS (QERA) AS THE RISKS REMAIN AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2011. THE PHYSICIAN IMPLANTED A ZENITH FLEX AAA MAIN BODY VIA THE RIGHT ILIAC AND THEN HE PUT A ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG UP THE CONTRALATERAL SIDE. AS HE WAS RETRIEVING THE TOP CAP, HE HAD ADVANCED THE GREY POSITIONER, DOCKING THE TOP CAP. HE HAD TIGHTENED THE PIN VISE AND UNDER FLUOROSCOPY HE WAS BRINGING DOWN THE TOP CAP THROUGH THE MAIN BODY. THE RESIDENT TOOK CONTROL AND HE CAME DOWN RATHER QUICKLY, (WE) BELIEVE HE CAUGHT A PART OF THE SUPRARENAL STENT CAUSING THE BARBS TO ENFOLD AND COLLAPSE ON ONE ANOTHER(1820334-2011-00212). THEY THEN TRIED TO REVERSE THE STEPS TO SEE IF THEY COULD DE-SNAG THE SUPRA RENAL STENT; HOWEVER, THIS DID NOT WORK. THE DEVICE WAS BROUGHT BACK THROUGH THE MAIN BODY, WHICH WAS NOT CAUGHT ON ANYTHING AT THE TIME. THERE WERE NO PROBLEMS BRINGING THAT OUT. A CODA BALLOON WAS BROUGHT UP TRYING TO OPEN UP THE SUPRA RENAL STENTS AND WHILE THEY WERE DOING SO, THE CODA BALLOON, AT AN UNK ATM, BURST (1820334-2011-00213). THIS HAPPENED RIGHT AWAY, POSSIBLY DUE TO BEING AROUND ALL THE RENAL STENTS. WE HAD NOTICED THAT EVERYTHING WAS INFRARENAL. BECAUSE OF THAT, THERE WAS NO CONCERN WITH THE RENALS BEING COVERED. WE CONTEMPLATED ON PUTTING IN A CUFF, BUT BECAUSE OF HOW THE STENTS WERE ENFOLDED THERE WAS NO WAY TO GET A SEAL THERE. AFTER WE HAD EXHAUSTED ALL OPTIONS, THEY DECIDED IT WAS BEST TO CONVERT TO OPEN REPAIR. PT IS RECOVERING AND DOING WELL.

    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 2661727

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention