BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT

    MDR report key: 1021941 · Received March 28, 2008

    Report

    Report Number
    1820334-2008-00218
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 27, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT IT WAS VERY DIFFICULT TO RELEASE THE TOP CAP FROM THE BODY OF THE GRAFT. HE HAS USED THIS GRAFT BEFORE AND STATED THAT HE HAS NEVER FOUND IT TO BE THIS DIFFICULT. WITH MUCH FORCE IT WAS EVENTUALLY RELEASED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA 1966304

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK