BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM -HYDRO

    MDR report key: 2100712 · Received May 18, 2011

    Report

    Report Number
    2953200-2011-01020
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: (ENDOLEAK), (UNK CAUSE OF TYPE III ENDOLEAK).

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 34 MONTHS AGO. AT THE TIME OF IMPLANT, THERE WERE BILATERAL COMMON AND INTERNAL ILIAC ARTERY ANEURYSMS AND A SMALL INFRARENAL AORTIC ANEURYSM. THE PT HAS END STAGE RENAL ARTERY DISEASE AND WILL HAVE A KIDNEY TRANSPLANT. THE ANEURYSMS HAVE TO BE TREATED PRIOR TO A KIDNEY TRANSPLANT. THE STENT GRAFT WAS IMPLANTED PARTIALLY COVERING THE RENAL ARTERY, AS THE PT WAS ALREADY IN RENAL FAILURE AND WAS ON DIALYSIS. THE ILIAC LIMBS WERE ALSO IMPLANTED AND THE ANEURYSMS WERE COVERED AND THE PT WAS FINE. APPROX ONE MONTH AGO, THE PT PRESENTED WITH BACK AND ABDOMINAL PAIN. THE CT DEMONSTRATED THAT THERE WAS A 6 CM ABDOMINAL AORTIC ANEURYSM WITH A GRAFT MATERIAL TYPE III ENDOLEAK, IN THE BIFURCATED STENT GRAFT, HOWEVER, NO PROXIMAL OR DISTAL ENDOLEAKS WERE PRESENT. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER MFR'S DEVICE AND THE TYPE III ENDOLEAK WAS RESOLVED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM -HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00107693

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention