BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1120004 · Received August 14, 2008

    Report

    Report Number
    2953200-2008-00688
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LACK OF INFORMATION (UNKNOWN CAUSE OF QUICK RELEASE BUTTON DISENGAGEMENT).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE QUICK RELEASE BUTTON WAS CHECKED TO ENSURE IT WAS LOCKED BEFORE THE DEVICE WAS INSERTED IN THE PATIENT. THE DEVICE WAS INSERTED AND AS THE STENT GRAFT WAS BEING DEPLOYED, IT WAS NOTED THAT THE QUICK RELEASE BUTTON WAS DISENGAGED AND IT WAS MOVING BACKWARDS. THE QUICK RELEASE BUTTON WAS ATTEMPTED TO BE RECONNECTED; HOWEVER, IT DID NOT REMAIN IN THE LOCKED POSITION. THE TECH ASSISTANT IN THE PROCEDURE HELD THE BACK END OF THE DELIVERY SYSTEM FIRMLY IN POSITION WHILE THE PHYSICIAN COMPLETED THE STENT GRAFT DEPLOYMENT. IT WAS CONFIRMED THAT THE STENT GRAFT WAS ACCURATELY DEPLOYED AT THE INTENDED LOCATION. THE DELIVER SYSTEM WAS IMMEDIATELY DISCARDED IN THE BIOHAZARD CONTAINER BEFORE THE REP COULD REQUEST ITS RETURN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00102691

    Patients

    Seq Age Sex Outcome Treatment
    1