BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1666443 · Received April 22, 2010

    Report

    Report Number
    2953200-2010-00706
    Event Type
    Death
    Date Received
    April 22, 2010
    Date of Event
    January 31, 2010
    Report Date
    March 23, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION RESULTS: (DEATH), (SYSTEMIC CLOTTING ISSUE).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.9 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 3.5 MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS MILD TORTUOSITY AND MODERATE CALCIFICATION. THE AORTIC NECK WAS STRAIGHT, 35 MM IN LENGTH, AND 22 TO 23 MM IN DIAMETER. IT WAS REPORTED THAT THE ANEURX STENT GRAFT WAS IMPLANTED WITHOUT ISSUES. HOWEVER, APPROXIMATELY 3.5 WEEKS POST-IMPLANTATION, THE PATIENT EXPIRED UNEXPECTEDLY FOLLOWING COMPLICATIONS FROM SURGERY AT A DIFFERENT HOSPITAL. IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF A SYSTEMIC CLOTTING ISSUE, AND NO FURTHER INFORMATION ABOUT THE CAUSE OF DEATH WILL BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00347591

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death