BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2120301 · Received June 2, 2011

    Report

    Report Number
    1820334-2011-00285
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 13, 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

    (B)(4). NO PRODUCT OR IMAGES RETURNED TO ASSIST WITH INVESTIGATION. 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 END USER. EACH DEVICE IS SENT WITH AN IFU, WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, CORRECT PRODUCT SIZING INSTRUCTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE THE INSTRUCTIONS FOR USE FOR THE MAIN BODY GRAFT STATE: "INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS." THE MAIN BODY IFU ALSO PROVIDES DETAILED INSTRUCTION ON PROPER PLACEMENT OF THE SUPRARENAL STENT IN ORDER TO MAINTAIN PATENCY OF RENAL ARTERIES, THE PROPER DEPLOYMENT SEQUENCE FOR RELEASING THE TOP CAP, AND DEPLOYMENT OF CONTRALATERAL AND IPSILATERAL LEGS, AND PROVIDES GUIDELINES FOR PROPER ANATOMICAL REQUIREMENTS. IN ADDITION, THE IFU PROVIDES INSTRUCTIONS ON PERFORMING ANGIOGRAPHY PRIOR TO TOP STENT DEPLOYMENT TO VERIFY THE POSITION OF THE GRAFT WITH RESPECT TO THE RENAL ARTERIES. STATING: "IF NECESSARY, CAREFULLY REPOSITION THE COVERED PORTION OF THE ENDOVASCULAR GRAFT WITH RESPECT TO THE RENAL ARTERIES. (REPOSITIONING CAN ONLY TAKE PLACE OVER A SMALL RANGE OF DISTANCE AT THIS STAGE.)" THE FAILURE MODE ASSIGNED TO THIS CASE IS DEPLOYMENT. THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION, AS WELL AS THE PHYSICIANS' COMMENTS: "THE MAINBODY MIGHT BE MIGRATED AT SOME UNK POINT DUE TO A SHORT PROXIMAL NECK LENGTH, WHICH RESULTED IN RENAL ARTERY OCCLUSION." IT APPEARS THAT THE DEVICE WAS USED OUTSIDE THE IFU IN THIS CASE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. NO FURTHER RISK REDUCTION ACTIVITIES PER QUALITY ENGINEERING RISK ASSESSMENT, THE RISKS REMAIN AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS NOT SUITABLE FOR THE ENDOVASCULAR REPAIR DUE TO SHORT PROXIMAL NECK LENGTH (AROUND 5MM), POOR ACCESS ROUTE FOR BOTH LEFT AND RIGHT SITES (LEFT: HEAVY CALCIFICATION, RIGHT: STENOSIS DIAMETER -> 3MM). ALSO, HE HAD TAA. HOWEVER, THE PROCEDURE WAS CONDUCTED AS LABELED. THE FINAL CONFIRMATORY ANGIOGRAPHY SHOWED THAT LEFT AND RIGHT RENAL ARTERIES WERE OCCLUDED. BALLOONING WAS PERFORMED TO DRAG DOWN THE MAINBODY, THEN THE BLOOD FLOW IN ONE OF THE RENAL ARTERIES WAS CONFIRMED. HOSPITALIZATION PERIOD WAS EXTENDED.

    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 F2615863

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention