BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX AAADVANTAGE STENT GRAFTSYSTEM - HYDRO

    MDR report key: 1706378 · Received May 28, 2010

    Report

    Report Number
    2953200-2010-00964
    Event Type
    Death
    Date Received
    May 28, 2010
    Date of Event
    April 28, 2010
    Report Date
    April 28, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVAL RESULTS DEATH; RUPTURED ANEURYSM PRIOR TO STENT GRAFT PLACEMENT. CONCLUSION: RUPTURED ANEURYSM PRIOR TO STENT GRAFT PLACEMENT.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT DEVICE WAS IMPLANTED INTO A PATIENT FOR THE EMERGENT TREATMENT OF A 7.3 CM RUPTURED ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK HAD MILD ANTERIOR ANGULATION. THE ILIAC VESSELS WERE 14 TO 15 MM IN DIAMETER, MILDLY CALCIFIED, AND NON-TORTUOUS. THE ANEURX STENT GRAFT SYSTEM WAS SUCCESSFULLY IMPLANTED; THE ANEURYSM WAS EXCLUDED WITHOUT ANY ENDOLEAKS, AND THE FINAL OUTCOME WAS VERY GOOD. IT WAS REPORTED THAT WHEN CLOSING UP THE PATIENT, THE PATIENT CODED, AND EXPIRED, NO RESUSCITATION WAS ATTEMPTED. THE PATIENT COULD NOT RECEIVE BLOOD BECAUSE OF RELIGIOUS REASONS. THERE WERE NO REPORTED DEVICE RELATED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFTSYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00400742

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death