BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 1983604 · Received February 1, 2011

    Report

    Report Number
    1820334-2011-00084
    Event Type
    Death
    Date Received
    February 1, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 19, 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) - CONVERSION TO OPEN REPAIR, HYPOTENSION, AND DEATH ARE LABELED IN THE IFU. (B)(4) - DAMAGE TO THE DELIVERY SYSTEM AND THE ZENITH AAA ENDOVASCULAR GRAFT ARE LABELED IN THE IFU. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST WITH THIS 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 USER. EACH DEVICE IS SENT WITH INSTRUCTIONS FOR USE (IFU), WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE THE IFU STATES: "VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION." "DO NOT BEND OR KINK THE DELIVERY SYSTEM. DOING SO MAY CAUSE DAMAGE TO THE DELIVERY SYSTEM AND THE ZENITH AAA ENDOVASCULAR GRAFT." "DO NOT CONTINUE ADVANCING ANY PORTION OF THE DELIVERY SYSTEM IF RESISTANCE IS FELT DURING ADVANCEMENT OF THE WIRE GUIDE OR DELIVERY SYSTEM. STOP AND ASSESS THE CAUSE OF THE RESISTANCE. VESSEL OR CATHETER DAMAGE MAY OCCUR. EXERCISE PARTICULAR CARE IN AREAS OF STENOSIS, INTRAVASCULAR THROMBOSIS OR IN CALCIFIED OR TORTUOUS VESSELS." THE FAILURE MODE ASSIGNED TO THIS CASE IS DEPLOYMENT. THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION. IT APPEARS THAT THE PT'S ANATOMY MAY HAVE BEEN OUTSIDE THE IFU DUE TO TORTUOSITY, HOWEVER, FILMS WERE NOT AVAILABLE TO REVIEW DURING THE COURSE OF THE INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. A QUALITY ENGINEERING RISK ANALYSIS (QERA) WAS PERFORMED AND NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A (B)(6) MALE PT, WITH A HISTORY OF AAA ISCHEMIC HEART DISEASE, EMPHYSEMA, AND HYPERTENSION, UNDERWENT AAA REPAIR. THE PT'S AAA WAS HIGHLY CURVED AND THE PROCEDURE WAS PLANNED TO APPROACH FROM THE RIGHT AND TO PLACE THE CONVERTER AT THE END. AFTER PLACEMENT OF THE MAINBODY AND THE ILIAC LEG GRAFTS, THE CONVERTER DELIVERY SYSTEM WAS INSERTED BUT WOULD NOT ADVANCE TO THE TARGET SITE. THE DELIVERY SYSTEM ADVANCED TO THE TARGET SITE BY CUTTING THE EXTERNAL ILIAC ARTERY, BUT IT BROKE BEFORE THE CONVERTER DEPLOYMENT. THUS THE PHYSICIAN MOUNTED THE CONVERTER ON THE MAINBODY DELIVERY SYSTEM AND ADVANCED IT TO THE TARGET SITE. THE CONVERTER WAS DEPLOYED, BUT THE GRAY POSITIONER AND THE TOP CAP WOULD NOT WITHDRAW AND REMOVE FROM THE SYSTEM, DUE TO HIGHLY CURVATURE OF THE PROXIMAL NECK AND THE AAA ITSELF. THUS THE PROCEDURE WAS CONVERTED TO THE OPEN SURGERY FOR ARTIFICIAL BLOOD VESSEL REPLACEMENT. THE PT DECEASED FROM HYPOTENSION DUE TO STRAIN ON THE HEART DUE TO AORTIC BLOCKAGE FOR OPEN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2589052

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death