BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 3231912 · Received July 11, 2013

    Report

    Report Number
    1820334-2013-00295
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 3, 2013
    Report Date
    July 1, 2013
    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

    LOT - UNK AS NOT PROVIDED BY REPORTER. EXPIRATION - UNK AS LOT IS UNK. (B)(4). DATE OF MANUFACTURE: UNK AS LOT IS UNK. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    INFO FROM A STUDY INDICATES THAT A (B)(6) FEMALE UNDERWENT EVAR ON (B)(6) 2013. THE PHYSICIAN PLACED ZENITH ENDOGRAFTS INCLUDING ILIAC LIMBS WITH SPIRAL-Z TECHNOLOGY. THE PT HAD MILD LEFT ILIAC DISEASE AND CALCIFICATION WITH MODERATE LEFT ILIAC TORTUOSITY. THE RIGHT ILIAC HAD NOT ILIAC OCCLUSIVE DISEASE BUT MILD CALCIFICATION AND TORTUOSITY. AS OF (B)(6) 2013, IT WAS NOTED THAT THE LEFT ILIAC LEG EXTENSION HAD TORTUOSITY. ADDITIONAL INFO RECEIVED FROM THE STUDY ON (B)(6) 2013 INDICATED THAT ANGIOPLASTY WAS PERFORMED IN THE LEFT NATIVE VESSEL BEFORE THE PROCEDURE AND AN UNCOVERED STENT WAS PLACED IN THE LEFT LEG/LEG EXTENSION AFTER THE PROCEDURE DUE TO TORTUOSITY. DEVICE(S) WERE PATENT AT THE CONCLUSION OF THE PROCEDURE WITH NO INDICATION OF EXTERNAL COMPRESSION, KINKS, THROMBUS, OR ENDOLEAKS. ALL ZENITH DEVICES REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320786 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH - SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention