BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1895365 · Received November 2, 2010

    Report

    Report Number
    2953200-2010-02112
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: ARTERIAL AND VENOUS OCCLUSION. OTHER, (PENDING EXPLANTED STENT GRAFT EVAL).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A VERY LARGE RIGHT COMMON ILIAC ARTERY ANEURYSM APPROXIMATELY 3 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF INITIAL IMPLANT ARE UNK. THE PT HAS LARGE ILIAC ARTERIES. IT WAS REPORTED THAT PT PRESENTED RECENTLY WITH OCCLUSION OF THE BIFURCATED STENT GRAFT EXTENSION AND BOTH ILIAC LIMBS. (MFG 2953200-2010-02112, MFG 2953200-2010-02113, AND MFG 2953200-2010-02114). THE PHYSICIAN ELECTED TO EXPLANT ALL THE STENT GRAFTS. THE EXPLANTED STENT GRAFTS HAVE BEEN RECEIVED BY MEDTRONIC, AND THE EVAL IS PENDING. NO ADDITIONAL 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 MIH MEDTRONIC CARDIOVASCULAR NA V00042354

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention