BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT CONVERTER

    MDR report key: 2032255 · Received March 17, 2011

    Report

    Report Number
    1820334-2011-00136
    Event Type
    Death
    Date Received
    March 17, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 16, 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): WIRE KINK. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AN (B)(6) FEMALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT WAS NOT SUITABLE FOR ENDOVASCULAR REPAIR BECAUSE THE PT'S PROXIMAL NECK WAS CROOKED 68 DEGREE BY THE ANEURYSM. AFTER INSERTED THE MAIN BODY, THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND THEN INSERTED THE ESC, BUT IT COULD NOT BE REMOVED FROM THE DELIVERY SYSTEM. THE PHYSICIAN RECOGNIZED THE WIRE GUIDE WAS KINKED AND STUCK WITH INNER CANNULA OF ESC. SO THE PHYSICIAN REMOVED THE DELIVERY SYSTEM WITH WIRE GUIDE. THEN THE PHYSICIAN ASSEMBLED THE ESC INTO THE MAIN BODY SHEATH AND TRIED TO INSERT, BUT IT COULD NOT BE DEPLOYED. FINALLY THE PHYSICIAN DECIDED TO TRANSITION TO OPEN SURGERY. <ADDITIONAL INFO (B)(6) 2011> THE PHYSICIAN CUT OFF THE MAIN BODY AT UNDER THE PROXIMAL SIDE OF FIRST STENT, THEN HE SUTURED WITH THE ARTIFICIAL VESSEL AND SAVED THE BLOOD FLOW TO BOTH SIDE OF THE CIA. <ADDITIONAL INFO (B)(6) 2011> THE PHYSICIAN PERFORMED OPEN SURGERY WITH THE SHEATH REMAINED THE PT'S PERIPHERALLY. THE VESSEL HAS BEEN CLAMPED IN THIS CONDITION FOR A LONG PERIOD, AND THE ISCHEMIC TIME HAS BEEN LENGTHENED, SUSPECTED TO HAVE CAUSED ISCHEMIA-REPERFUSION INJURY.

    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 F2568899

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death