BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 868969 · Received June 22, 2007

    Report

    Report Number
    2953200-2007-00260
    Event Type
    Death
    Date Received
    June 22, 2007
    Date of Event
    March 2, 2007
    Report Date
    May 30, 2007
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS SUCCESSFULLY IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED 3 MONTHS POST STENT GRAFT IMPLANT WITH A HIGH CREATININE LEVEL. THE CT DEMONSTRATED THAT THE STENT GRAFT WAS CORRECTLY PLACED AND WAS NOT COVERING THE RENAL ARTERIES. IT WAS REPORTED THAT THE ONE MONTH LATER, THE PATIENT EXPIRED. THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN. THE FAMILY DID NOT WANT AN AUTOPSY PERFORMED. THE NEPHROLOGIST BELIEVES THAT THE POSSIBLE CAUSE OF THE PATIENT'S HIGH CREATININE LEVEL COULD BE A STRANGE/RARE THROMBOLYTIC EVENT WHICH MAY HAVE BEEN RELATED TO A REACTION BETWEEN THE PATIENT'S GENETIC MAKE UP AND THE IMPLANTATION OF THE STENT GRAFT. SINCE AN AUTOPSY WAS NOT PERFORMED AND THE DEVICE WAS NOT RETURNED TO MEDTRONIC A COMPLETE INVESTIGATION CAN NOT BE PERFORMED. THERE IS NO FURTHER INFORMATION AVAILABLE TO MAKE A CONCLUSION REGARDING DEVICE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC VASCULAR NA 1000155

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death