BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1831792 · Received September 8, 2010

    Report

    Report Number
    1820334-2010-00447
    Event Type
    Death
    Date Received
    September 8, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 9, 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

    INFECTION IS LABELED IN THE IFU. SURGICAL CONVERSION TO OPEN REPAIR IS LABELED IN THE IFU. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION. THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS SHOWING THE DEVICE MEETS PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. AN IFU IS SHIPPED WITH EACH DEVICE LISTING THE INDICATIONS OF USE, WARNINGS AND PRECAUTIONS, CONTRAINDICATIONS, AND THE PROPER DEPLOYMENT SEQUENCE. ADDITIONAL, THE IFU STRESSES THE IMPORTANCE TO MINIMIZE HANDLING OF THE CONSTRAINED ENDOPROSTHESIS DURING PREPARATION TO DECREASE THE RISK OF CONTAMINATION AND INFECTION. COOK HAS PROCEDURES IN PLACE TO MONITOR AND CONTROL THE MFG ENVIRONMENT. SPECIFICALLY FOR THE ZENITH FAMILY OF PRODUCTS, BIOBURDEN AND ENDOTOXIN LEVELS ARE TESTED QUARTERLY. PT UNDERWENT EVAR ON (B)(6)2007, AND ENDOGRAFT EXPLANTED THREE YEARS POST-IMPLANT BECAUSE OF INFECTION. THE PHYSICIAN ADDED THAT THEY DID NOT BELIEVE THE INFECTION WAS RELATED TO THE DEVICE. DETAILS CONCERNING PT FOLLOW-UP AFTER INITIAL REPAIR AND INFECTION ETIOLOGY WERE NOT PROVIDED. THE PT PASSED TWO DAYS AFTER OPEN REPAIR DUE TO MYOCARDIAL INFARCTION. THE PT HAD PRE-EXISTING CARDIAC CONDITIONS, BUT DETAILS WERE NOT PROVIDED. AT THIS TIME, THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTED IN INFECTION AND SUBSEQUENT DEATH. HOWEVER, THE COMPLAINT WILL BE TRENDED AS CRITICAL HARM/DEATH. IT IS DIFFICULT TO DETERMINE HOW INTERVENTION IMPACTED THE HEALTH OF THE PT. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED AND THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH THE INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6)2007. THE PT RECEIVED A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND TWO ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INCIDENT. ON (B)(6)2010, THE PT UNDERWENT AN ADDITIONAL PROCEDURE TO EXPLANT THE ZENITH AAA COMPONENTS. THE PT HAD DEVELOPED AN INFECTION IN THE ANEURYSM SAC THAT HAD ERODED THROUGH THE BACK OF THE AORTA WALL AND FILLED THE SAC WITH PUS. THE EXPLANT WAS DONE TO REMOVE ALL OF THE GRAFT AND ESTABLISH NEW BYPASS FLOW EXCLUDING THE AORTA. A SPLEEN TO RENAL BYPASS WAS ALSO COMPLETED. THE SURGEON STATED THAT THEY DO NOT BELIEVE THE INFECTION TO BE DUE TO THE ZENITH DEVICE SINCE THE INFECTION WAS THREE YEARS POST-IMPLANT. PT HAD A MYOCARDIAL INFARCTION TWO DAYS POST-OP LEADING TO EXPIRATION.

    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 1897355

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R