BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1854545 · Received September 29, 2010

    Report

    Report Number
    2953200-2010-01838
    Event Type
    Death
    Date Received
    September 29, 2010
    Date of Event
    August 29, 2010
    Report Date
    August 30, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: DEATH, ANEURYSM RUPTURE, ENDOLEAK, MIGRATION. RESULTS/CONCLUSIONS: LACK OF INFO. ANALYSIS OF THE EXPLANTED STENT GRAFT IS PENDING.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM 38 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WAS NOT REPORTED. IT WAS REPORTED THAT THE PT PRESENTED TO THE ER IN THE MIDDLE OF THE NIGHT WITH A RUPTURED ANEURYSM. IT WAS NOTED THAT THE PROXIMAL END OF THE GRAFT WAS FLOATING FREELY WITHIN THE ANEURYSM SAC; HOWEVER, DISTALLY IT WAS WELL INCORPORATED. THE DECISION WAS MADE TO EXPLANT THE STENT GRAFT; HOWEVER, THE PT EXPIRED LATER THE SAME DAY. THE EXPLANTED STENT GRAFT WAS RETURNED AND ITS ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 1001143

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death