BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH

    MDR report key: 2111940 · Received June 2, 2011

    Report

    Report Number
    2031527-2011-00030
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT DATE READS: (B)(4) 2011, SHOULD READ: (B)(4) 2011.

    Additional Manufacturer Narrative · 1

    EXPIRATION AND IMPLANT DATE UNKNOWN (COMPETITOR DEVICE). DEVICE MANUFACTURE DATE UNKNOWN (COMPETITOR DEVICE). ZENITH DEVICE IS NOT MANUFACTURED BY ENDOLOGIX.

    Description of Event or Problem · 1

    PATIENT HAD A PREVIOUS IMPLANT, DATE UNKNOWN, OF AN UNKNOWN COOK DEVICE IN NON-ANEURYSMAL AORTA, TO TREAT AN AORTIC DISSECTION. A FOLLOW UP REVEALED A PROXIMAL AND A DISTAL ENDOLEAK. ON (B)(6) 2011 THE PATIENT WAS TREATED WITH A 25-16-140BL BIFURCATED DEVICE WHICH CORRECTED BOTH THE PROXIMAL AND DISTAL ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION MIH COOK, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention