BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 870838 · Received June 26, 2007

    Report

    Report Number
    2953200-2007-00267
    Event Type
    Death
    Date Received
    June 26, 2007
    Date of Event
    April 21, 2007
    Report Date
    June 4, 2007
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS SUCCESSFULLY IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL AND ANEURYSM MORPHOLOGY IS UNKNOWN. IT WAS REPORTED A FEW DAYS POST STENT GRAFT IMPLANT THE PATIENT RETURNED DUE TO THE HOSPITAL, DUE TO INTESTINAL ISCHEMIA AND SUBSEQUENTLY THE PATIENT EXPIRED THE FOLLOW DAY. PRIOR TO THE STENT GRAFT IMPLANT TO PATIENT'S CREATINE LEVEL WAS 4.0; THE PATIENT WAS HYDRATED PRIOR TO ENDOVASCULAR CASE. THE PATIENT HAD RENAL ARTERY OCCLUSION PRIOR TO STENT GRAFT IMPLANT. THE PHYSICIAN DOES NOT BELIEVE THAT THE PATIENT'S DEATH IS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC VASCULAR NA 1001133

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death