BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX AAADVANTAGE BIFURCATED HYDRO

    MDR report key: 1053073 · Received May 23, 2008

    Report

    Report Number
    2953200-2008-00359
    Event Type
    Death
    Date Received
    May 23, 2008
    Date of Event
    April 19, 2008
    Report Date
    April 30, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (DEATH). (PRESENTED WITH A RUPTURED ANEURYSM PRIOR TO DEVICE PLACEMENT). CONCLUSION: (PRESENTED WITH A RUPTURED ANEURYSM PRIOR TO DEVICE PLACEMENT). (ANEURYSM RUPTURED PRIOR TO STENT GRAFT PLACEMENT).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A RUPTURED ANEURYSM AT A SMALL HOSPITAL. THE PATIENT WAS FLOWN TO A LARGER HOSPITAL. THE PHYSICIAN ELECTED AN ENDOVASCULAR REPAIR FOR TREATMENT. IT WAS REPORTED THAT THE PATIENT EXPIRED THE FOLLOWING DAY, POST STENT GRAFT IMPLANT DUE TO THE BLOOD LOSS FROM THE RUPTURED ANEURYSM PRIOR TO STENT GRAFT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE BIFURCATED HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00086698

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death