BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT LLIAC LEG

    MDR report key: 5415809 · Received May 27, 2010

    Report

    Report Number
    1820334-2010-00197
    Event Type
    Death
    Date Received
    May 27, 2010
    Date of Event
    March 13, 2010
    Report Date
    March 13, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT OR IMAGING WERE RETURNED 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 ANATOMICAL CRITERIA, INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. INITIAL REPAIR PERFORMED (B)(6) 2007. BASED ON THE COMPLAINT CORRESPONDENCE, DIFFICULTY DEPLOYING THE DEVICE DUE TO THE PATIENTS TORTUOUS ANATOMY WAS NOT REPORTED DURING THE INITIAL REPAIR. WITH THE INFORMATION PROVIDED, THE PATIENTS ANATOMY LIKELY CONTRIBUTED TO THE DIFFICULT DEPLOYMENT AND INITIAL DISCONNECTION. THE DISCONNECTION THAT WAS IDENTIFIED WHEN PATIENT PRESENTED EMERGENTLY IS INVESTIGATED UNDER 1820334-2010-00197. WITHOUT IMAGING OR ADDITIONAL INFORMATION WE ARE UNABLE TO DETERMINE THE PATIENTS SUITABILITY FOR EVAR. HOWEVER, THE COMPLAINT CORRESPONDENCE INDICATES THAT THE PHYSICIAN UNDERSTOOD THAT THE PATIENTS ANATOMY PRESENTED OBSTACLES TO SUCCESSFUL EVAR AND WAS OUTSIDE THE IFU. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    AN (B)(6) MALE PATIENT, WHOSE ANATOMY WAS NOT CONDUCTIVE, UNDERWENT AAA REPAIR ON (B)(6) 2007. THE PATIENT RECEIVED A ZENITH MAIN BODY, 3 ZENITH ILIAC LEGS, AND 1 ZENITH MAIN BODY EXTENSION. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED INCIDENT. HE AWOKE SATURDAY (B)(6) 2010 WITH BACK PAIN THAT DOUBLED HIM OVER HE WENT TO THE EMERGENCY ROOM WHERE HE WAS SCANNED AND THE PHYSICIAN SAW THERE WAS A DISCONNECT IN ONE OF THE LIMBS FROM THE MAIN BODY. THE PATIENT'S ANATOMY WAS INCREDIBLY TORTUOUS AND THE PHYSICIANS HAD TROUBLE PLACING THE INITIAL GRAFT (1820334-2010-00196) UPON PLACING THE INITIAL GRAFT, THEY HAD A DISCONNECT OF ONE OF THE LIMBS BEFORE THE END OF SURGERY AND HAD TO BRIDGE IT WITH ANOTHER LEG. THE PHYSICIAN'S PLAN WAS TO TRY TO GAIN ACCESS ON THE STILL CONNECTED SIDE AND BRIDGE THE AREA THAT HAD DISCONNECTED (1820334-2010-00197). IF HE WAS UNABLE TO DO THIS IN A REASONABLE AMOUNT OF TIME, HE PLANNED TO CONVERT THE PATIENT WITH A RENU CONVERTER TO AN AORTO-UNI-LLIAC. THE FIRST ANGIOGRAM WAS PERFORMED, WHICH REVEALED THAT BOTH LIMBS WERE DISCONNECTED. THE PHYSICIAN HAD A HARD TIME WITH ACCESS. AN ATTEMPT WAS MADE TO PLACE THE RENU DEVICE UP THE RIGHT SIDE, BUT THE DEVICE WOULD NOT TRACK HIGH ENOUGH TO DEPLOY IT. THE PATIENT'S BLOOD PRESSURE STARTED TO BECOME UNSTABLE AND THE PHYSICIAN MADE THE CHOICE TO CONVERT THE PATIENT TO OPEN SURGERY. THE PATIENT LOST TOO MUCH BLOOD AND HE DIED ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT LLIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1756628

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death