BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1000527 · Received February 21, 2008

    Report

    Report Number
    2953200-2008-00066
    Event Type
    Death
    Date Received
    February 21, 2008
    Date of Event
    August 25, 2006
    Report Date
    January 25, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED INTO A PT FOR THE ELECTED ENDOVASCULAR TREATMENT OF AN ASYMPTOMATIC 4.7CM ABDOMINAL AORTIC ANEURYSM. THERE WAS REPORT OF A SMALL TYPE II ENDOLEAK AT THE END OF THE PROCEDURE. IT WAS REPORTED THAT THE PT RETURNED 7 DAYS POST STENT GRAFT IMPLANT WITH FATIGUE, SYNCOPE, AND SHORTNESS OF BREATH. IT WAS REPORTED THAT THE PT'S RIGHT AND LEFT EXTERNAL ILIAC, COMMON FEMORAL SUPERFICIAL FEMORAL, POPLITEAL, POSTERIOR TIBIAL AND PERONEAL VEINS DEMONSTRATED GOOD COLOR FLOW, VENOUS WAVEFORMS AND AUGMENTATION OF FLOW. THE PT HAS ACUTE RENAL FAILURE WHICH THE PHYSICIAN BELIEVES IS RELATED TO ACUTE TUBULAR FROM DECREASED RENAL PERFUSION FROM HYPOTENSION. THE PT WAS TREATED FOR ACUTE LUNG INJURY WITH DIFFUSE ELEOTRIS DAMAGE WHICH THE PHYSICIAN BELIEVES MAY BE RELATED TO AMIODARONE TREATMENT. THE PT HAD A LUNG BIOPSY OF THE LOWER LEFT LOBE REVEALING THAT THE PT HAD INTERSTITIAL LUNG DISEASE. THE PT WAS ON A MECHANICAL VENTILATOR DUE TO RESPIRATORY FAILURE. IT WAS REPORTED THAT THE PT EXPIRED 30 DAYS POST STENT GRAFT IMPLANT DUE TO RESPIRATORY FAILURE DUE TO INTERSTITIAL FIBROSIS CAUSED BY AMIODARONE TOXICITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA B14906

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death