BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 3731640 · Received March 27, 2014

    Report

    Report Number
    1820334-2014-00145
    Event Type
    Injury
    Date Received
    March 27, 2014
    Date of Event
    December 10, 2013
    Report Date
    March 7, 2014
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PT HAD EVAR PROCEDURE ON (B)(6) 2013 FOR AORTOILIAC ANEURYSM (AORTIC DIAMETER - 50MM; LEFT ILIAC DIAMETER AT AORTIC BIFURCATION - 23 MM; RIGHT ILIAC DIAMETER AT AORTIC BIFURCATION - 30 MM). ILIAC ANEURYSM CLASSIFICATION V. COMPLETION ANGIOGRAM SHOWED PT DEVICES WITH NO EVIDENCE OF EXTERNAL COMPRESSION, FLOW-LIMITING KINK, THROMBUS, OR ENDOLEAKS. ON (B)(6) 2013 (47 DAYS POST-PROCEDURE), PT EXPERIENCED AMPUTATION RELATED TO LOWER EXTREMITY. FOLLOW-UP CT ON (B)(6) 2014 (78 DAYS POST-PROCEDURE), SHOWED NO CHANGE IN THE ANEURYSM STATUS, NO EXTERNAL COMPRESSION, NO FLOW-LIMITING KINK, NO MIGRATION OR ENDOLEAK. THERE WAS OCCLUSION OF THE RIGHT ILIAC LEG AND THROMBUS IN THE MAIN BODY AND RIGHT ILIAC LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179748 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 54 YR Required Intervention