BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 4745989 · Received April 27, 2015

    Report

    Report Number
    1820334-2015-00253
    Event Type
    Injury
    Date Received
    April 27, 2015
    Date of Event
    August 11, 2014
    Report Date
    March 30, 2015
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    EVENT EVAL: DURING INVESTIGATION, A REVIEW OF THE COMPLAINT REPORT, DEVICE COMPLAINT HISTORY AND TRENDS AND THE INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED. 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 IFU, WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, AND THE PROPER DEPLOYMENT SEQUENCE SPECIFIC TO THIS CASE, THE IFU STATES. SPECIFIC TO THIS CASE ZENITH IFUS STATE "ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO CLAUDICATION (E G , BUTTOCK, LOWER LIMB)". MINIMAL INFORMATION WAS PROVIDED TO ASSIST WITH THIS CASE. IT IS UNCLEAR WHERE THE CLAUDICATION OCCURRED OR IF IT WAS RELATED TO PRE-EXISTING ANATOMICAL CONDITIONS OR USE OF THE DEVICE.

    Description of Event or Problem · 1

    A (B)(6)-YR-OLD MALE PT IN THE SPIRAL-Z POST-MARKET REGISTRY EXPERIENCED CLAUDICATION (LOWER LIMB OR BUTTOCK). THE PT WAS TREATED ON (B)(6) 2013 FOR AN AORTOILIAC ANEURYSM. THE MAXIMUM AORTIC DIAMETER WAS 30 MM. THE PROXIMAL NECK HAD A PARALLEL SHAPE WITH PARTIAL PLAQUE/THROMBUS. THE BILATERAL ILIAC ARTERIES HAD NOT TORTUOSITY, SEVERE OCCLUSIVE DISEASE, AND SEVERE CALCIFICATION. THE PT RECEIVED A MAIN-BODY DEVICE, A LEFT ILIAC LEG, AND A RIGHT ILIAC LEG. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE COMPONENTS. NO OTHER PROCEDURES WERE PERFORMED AN NO ADDITIONAL DEVICES WERE USED. A MOLDING BALLOON WAS USED BUT NO DETAILS WERE PROVIDED REGARDING ITS USE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, ENDOLEAKS OR THROMBUS. ON (B)(6) 2014 (43 DAYS POST-PROCEDURE), THE PT WAS SEEN IN FOLLOW-UP. THERE HAD BEEN NO CHANGE IN THE SIZE OF THE ANEURYSM. DEVICES WERE PT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, THROMBUS, ENDOLEAK OR MIGRATION. ON (B)(6) 2014 (252 DAYS POST-PROCEDURE), THE PT EXPERIENCED CLAUDICATION (LOWER LIMB OR BUTTOCK). NO OTHER INFORMATION REGARDING THE EVENT IS AVAILABLE. ON (B)(6) 2014 (354 DAYS POST-PROCEDURE), THE PT WAS SEEN IN FOLLOW-UP. THERE HAD BEEN NO CHANGE IN THE SIZE OF THE ANEURYSM. DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, THROMBUS, ENDOLEAK OR MIGRATION. NO FURTHER FOLLOW UP VISITS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276288 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other