BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1910515 · Received November 19, 2010

    Report

    Report Number
    2953200-2010-02287
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: ARTERIAL TRAUMA/DISSECTION/PERFORATION, SEVERELY TORTUOUS WITH 60 DEGREES BENDS IN THE VESSELS.

    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 1 MONTH AGO. (MFR 2953200-2010-02287) VESSEL MORPHOLOGY WAS REPORTED AS MILDLY CALCIFIED, AND SEVERELY TORTUOUS WITH 60 DEGREES BENDS. THERE WAS AN ILIAC ANEURYSM MEASURING 16 MM IN DIAMETER. IT WAS REPORTED THAT A RELIANT BALLOON WAS USED TO MODEL THE ILIAC STENT GRAFT. THE RELIANT BALLOON WAS WITHIN THE ILIAC STENT GRAFT WHEN IT WAS INFLATED WITH THE USE OF A 30 CC SYRINGE WITH 70% SALINE AND 30% CONTRAST SOLUTION AND UPON INFLATION THE ILIAC VESSEL WAS PERFORATED. (MFR 2953200-2010-02288) THE PHYSICIAN IMPLANTED AN ILIAC STENT GRAFT EXTENDING DOWN TO THE LEVEL OF THE HYPOGASTRIC ARTERY AND PERFORATION WAS RESOLVED. 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 - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00512078

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention