BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2943400 · Received January 29, 2013

    Report

    Report Number
    1820334-2013-00052
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    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). EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO OCCLUSIONS, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS; ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, IMPORTANCE OF ACCURATE PLACEMENT. 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." THE PHYSICIAN IN THIS CASE REQUESTED ADDITIONAL INFORMATION AS TO WHAT MAY HAVE LEAD TO THE OCCLUSION IN THIS CASE. ALTHOUGH THERE IS SOME INDICATION TO BELIEVE IMAGING WOULD BE RETURNED, NONE HAD YET TO HAVE BEEN RECEIVED AT THE TIME THIS REPORT WAS WRITTEN. THE PROVIDED INFORMATION IN THIS CASE WAS FORWARDED FOR AN INDEPENDENT REVIEW AND IMPRESSION. THE INDEPENDENT REVIEWER STATES: "THE CAUSES OF LIMB OCCLUSION ARE POOR INFLOW, LIMB STENOSIS, POOR OUTFLOW, AN UNTREATED HYPERCOAGULABLE STATE, OR A COMBINATION OF THESE." THE PHYSICIAN ALSO INQUIRED IN THIS CASE, "NUMBER OF EVENT REPORT INVOLVING WARFARIN-TREATED PATIENTS (IF THERE IS". STATISTICS REGARDING WARFARIN TREATED PATIENTS ARE NOT KEPT BY COOK, AS THIS INFORMATION MAY BE PROVIDED BUT IS NOT REQUIRED AND TYPICALLY NOT RETURNED. THUS THE RAW DATA NECESSARY TO COMPILE SUCH A RESPONSE IS NOT COMPLETE OR READILY AVAILABLE. THE INFORMATION AVAILABLE IN THE COMPLAINT FILE, THE DEVICE IFU, APPLICABLE RISK ASSESSMENTS, INDEPENDENT REVIEW, AND COMPLAINT HISTORY WERE REVIEWED AS PART OF THE INVESTIGATION. RISK ASSESSMENTS WERE USED TO EVALUATE RISK. THE RISKS REMAINS ACCEPTABLE WITH INCLUSION OF THIS EVENT AND THE EVENT WAS TRENDED AS SERIOUS HARM TO THE PATIENT. THE FAILURE MODE ASSIGNED TO THIS CASE IS OCCLUDED. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CAN NOT BE DETERMINED OR REPORTED. IT SHOULD BE NOTED THAT LITTLE INFORMATION WAS PROVIDED TO ASSIST WITH THIS INVESTIGATION. THE RISK REMAINS ACCEPTABLE WITH INCLUSION OF THIS EVENT AND THE EVENT WAS TRENDED AS SERIOUS HARM TO THE PATIENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND NOTIFY THE APPROPRIATE PERSONNEL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A (B)(6) MALE PATIENT RECEIVING WARFARIN THERAPY FOR CHRONIC ATRIAL FIBRILLATION UNDERWENT AAA REPAIR. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE ENDOVASCULAR REPAIR. A MAIN BODY AND TWO ILIAC LEG GRAFTS WERE USED FOR THE PROCEDURE. ONE ILIAC LEG GRAFT WAS PLACED IN THE RIGHT ILIAC ARTERY WITH COIL EMBOLIZATION OF THE INTERNAL ILIAC ARTERY AND THE OTHER ILIAC LEG GRAFT WAS PLACED IN THE LEFT COMMON ILIAC ARTERY. UPON DEPLOYMENT, DOPPLER CONFIRMED THE ABSENCE OF BLOOD FLOW IN THE LEFT LEG. HOWEVER, FLOW WAS RE-ESTABLISHED AFTER A SHORT TIME, SO A WAIT AND SEE APPROACH WAS ADOPTED. IN (B)(6) 2012, OCCLUSION OF THE RIGHT LEG WAS CONFIRMED (1820334-2013-00051). ON (B)(6) 2013, THE PATIENT WAS ADMITTED DUE TO OCCLUSION OF BOTH LEGS (1820334-2013-00052) AND AN EMERGENCY OPEN SURGERY WAS PERFORMED. THE ZENITH STENT GRAFTS WERE TAKEN OUT AND VASCULAR PROSTHESES WERE IMPLANTED. THE PATIENT HAS NOT BEEN RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39500 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention