BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1993436 · Received February 8, 2011

    Report

    Report Number
    1820334-2011-00067
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    February 2, 2009
    Report Date
    January 11, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDITIONAL SURGICAL REPAIR IS NOT SPECIFICALLY ADDRESSED IN THE IFU. ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2009. THE PT WAS NOT SUITABLE ENDOVASCULAR REPAIR BECAUSE THE PT'S PROXIMAL NECK WAS SHORT. DURING THE PROCEDURE, THE PHYSICIAN RECOGNIZED A PROXIMAL TYPE I ENDOLEAK. SO THE PHYSICIAN PLACED ANOTHER MANUFACTURER'S STENT AND RESOLVED THE ENDOLEAK. THE PT REPORTED ANEMIA AND THE PHYSICIAN RECOGNIZED THE SUPRARENAL STENT WAS PENETRATED AND A FALSE ANEURYSM OCCURRED. (1820334-2011-00065). THE PHYSICIAN DECIDED THE PT KEEP UNDER OBSERVATION BECAUSE THE PT HAS EXPERIENCED A FEW OPEN SURGERIES IN THE PAST. THE PT KEPT UNDER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F224931

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention