BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1822781 · Received August 27, 2010

    Report

    Report Number
    1820334-2010-00405
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    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

    SEPARATES IS NOT SPECIFICALLY ADDRESSED PER THE IFU. EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD, MALE, PATIENT, UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PATIENT'S ANATOMICAL FORM WAS NOT SUITABLE FOR ENDOVASCULAR REPAIR BECAUSE THE PATIENT'S BOTH SIDES OF ACCESS ROUTE DIAMETER WAS NARROWED (RIGHT 4.2MM, LEFT 4.0MM). THE PHYSICIAN CONDUCTED THE PROCEDURE AS LABELED. HE THEN DID AN ANGIOGRAM AND RECOGNIZED THAT THE PROXIMAL SIDE ON THE CONTRALATERAL LEG WAS UNCOUPLED AND DROPPED INTO THE ANEURYSM. SO THE PHYSICIAN PLACED THE ADDITIONAL ILIAC LEG. THE ADDITIONAL ILIAC LEG WAS COVERED A LITTLE BIT OF THE LEFT INTERNAL ILIAC ARTERY, BUT RECOGNIZED KEEP BLOOD FLOWING AND THE PHYSICIAN ENDED THE PROCEDURE. THE PHYSICIAN CONFIRMED THAT THE ADDITIONAL LEG WAS PLACED PROPERLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2504986

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention