BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1901332 · Received November 12, 2010

    Report

    Report Number
    1820334-2010-00557
    Event Type
    Death
    Date Received
    November 12, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 14, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT OR IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. THE ZENITH DEVICE HAS COMPLETED 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. THE COMPLAINT DEVICE WAS SHIPPED WITH AN IFU THAT STATES IN THE "IMPLANT PROCEDURE" UNDER SECTION 4 "WARNINGS AND PRECAUTIONS", "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 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. A DEFINITIVE ROOT CAUSE CAN NOT BE REPORTED OR DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED TO COOK: ON (B)(6) 2010, A FEMALE PT UNDERWENT EVAR WITH A FLEX MAIN BODY-ZT PLACED UP THE PT'S RIGHT ILIAC, AN ILIAC LEG GRAFT-ZT WAS PLACED IN THE CONTRALATERAL (LEFT) SIDE, WHILE TRYING TO REMOVE THE MAIN BODY CAP, THE TOP CAP WOULD NOT FIT ONTO THE DILATOR. AFTER TRYING, THE MAIN BODY DEVICE WAS REMOVED AND THE PT'S ILIAC ARTERY CAME OUT ON THE DEVICE. ANOTHER ILIAC LEG GRAFT WAS PLACED ON THE IPSILATERAL (RIGHT) SIDE, THEN A ILIOFEMORAL BYPASS WAS PERFORMED. THIS FOLLOWING INFO WAS SENT TO THE (B)(4) FROM THE (B)(4) AT THE OFFICE: POST OPERATIVELY, SHE HAD ACUTE RENAL FAILURE, THROMBOCYTOPENIA, AND MYOCARDIAL INFARCTION. THE PT DECOMPENSATED DESPITE MULTIPLE PRESSORS AND FLUID RESUSCITATION ON (B)(6). ADDITIONAL INFO: THE REASON THE TWO PIECES, THE TOP CAP AND DILATOR WOULDN'T GO TOGETHER WAS BECAUSE OF A CHUNK OF PLAQUE. BLOOD TRANSFUSIONS WERE ADMINISTERED. PT DECEASED.

    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 2423744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death