BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1667337 · Received April 21, 2010

    Report

    Report Number
    1820334-2010-00172
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 22, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4), PER IFU. EVENT EVAL: 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 AN 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 RESISTANCE. VESSEL OR CATHETER DAMAGE MAY OCCUR. EXERCISE PARTICULAR CARE IN AREAS OF STENOSIS, INTRAVASCULAR THROMBOSIS OR IN CALCIFIED OR TORTUOUS VESSELS." THE DEVICE WAS RETURNED WITH THE GRAFT STILL LOADED UNDER THE SHEATH. MULTIPLE TWISTS AND BENDS IN THE DELIVERY SYSTEM AND SHEATH WERE OBSERVED. A BEND IN THE CANNULA, DISTAL TO THE PIN VISE WAS OBSERVED. THE LES WIRE WAS NOT ABLE TO BE REMOVED FROM THE INNER CANNULA, INDICATING A KINK WAS MOST LIKELY PRESENT, PINCHING THE WIRE GUIDE INSIDE OF THE LUMEN OF THE CANNULA. THE SPACING OF THE DELIVERY SYSTEM WAS MEASURED AND PHOTOGRAPHED. THE SHEATH OF THE DELIVERY SYSTEM WAS PULLED BACK AND THE TRIGGER WIRES WERE REMOVED FROM THE GRAFT. THE GRAFT WAS THEN REMOVED FROM THE TOP CAP. UPON REMOVAL OF THE GRAFT, IT WAS OBSERVED THAT MULTIPLE BENDS WERE PRESENT IN THE CANNULA. IT CAN REASONABLY BE DETERMINED THAT THE DELIVERY SYSTEM WAS EXPOSED TO EXCESSIVE TORTUOSITY OF VESSELS AND/OR EXCESSIVE FORCES, DURING THE PROCEDURE IN THE CASE, AND THAT THE PTS ANATOMICAL FORM WAS NOT SUITABLE FOR ENDOVASCULAR REPAIR. THE FAILURE MODE ASSIGNED TO THIS CASE IS "ADVERSE PHYSIOLOGICAL RESPONSE". THIS FAILURE MODE WAS DETERMINED BASED ON EVENT DESCRIPTION AND THE EXAMINATION OF RETURNED DEVICE. THE PT ANATOMY MAY HAVE BEEN A CONTRIBUTING FACTOR TO THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    ON (B) (6) 2010 A MALE PT, THAT EXHIBITED A TORTUOUS ANATOMY, ESPECIALLY THE ILIACS AND EXTERNALS, WENT FOR AN AAA REPAIR. THE PHYSICIAN ASSESSED THE RIGHT SIDE ACCESS WITH A DILATOR FROM A 16 FRENCH SHEATH. THE DILATOR PASSED AND THE PHYSICIAN CALLED FOR THE ZENITH MAIN BODY. THE PHYSICIAN WAS STRUGGLING TO GET THE SYSTEM UP. THE COMPANY REPRESENTATIVE (REP) WAS PRESENT AND OBSERVED THE PHYSICIAN'S FORWARD PUSHING OF THE DEVICE, SLID THE SHEATH FORWARD, CREATING A GAP BETWEEN THE DILATOR TIP AND SHEATH, I.E. THERE WAS NO LONGER A SMOOTH TRANSITION FROM THE DILATOR TO THE SHEATH. THE REP NOTED THAT THE PHYSICIAN WAS PUSHING VERY HARD AND OBSERVED THE END OF THE DEVICE COILED UP TOWARDS THE AREA OF WHERE THE DILATOR TIP WAS ON THE SCREEN UNDER X-RAY. THE PHYSICIAN BROUGHT THE DEVICE BACK OUT AND THE TRANSITION LOOKED OKAY, SO THE REP THEN ASKED FOR THE SHEATH TO BE PULLED BACK OVER THE DILATOR ABOUT 1CM. THE TRANSITION LOOKED GOOD AGAIN, BUT THE SHEATH LOOKED LIKE IT WAS STRESSED DUE TO THE TORTUOSITY. THE PHYSICIAN WAS CONCERNED THAT IT WASN'T GOING TO WORK. THE PT'S BLOOD PRESSURE WAS IN QUESTION BECAUSE THE ANESTHESIA WAS GIVING SOMETHING TO BRING IT BACK UP. THE PT'S BELLY WAS NOTED TO LOOK DISTENDED AND THE CONTRAST RUN TO ASSESS IF THE AORTA HAD RUPTURED, DID NOT INCLUDE THE EXTERNAL. THE PHYSICIAN QUICKLY GOT THE CODA BALLOON UP AND CLAMPED THE AORTA AT THE RENAL FROM THE LEFT SIDE AND CONVERTED TO OPEN REPAIR. THE REP DID NOT STAY FOR THE OPEN REPAIR. RECEIVED ADDITIONAL INFO ON APRIL 01, 2010. WHEN THE PHYSICIAN PULLED THE DEVICE OUT AFTER AN UNSUCCESSFUL ATTEMPT TO GET THE SYSTEM UP, THE LUNDERQUIST WIRE CAME OUT WITH THE DEVICE. THE PT EXPIRED ON (B) (6) 2010. NO ADDITIONAL INFO HAS BEEN PROVIDED BY THE RPTR.

    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 2349499

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death