BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM

    MDR report key: 1080772 · Received July 23, 2008

    Report

    Report Number
    2953200-2008-00588
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: LACK OF INFO, NO FILMS OR OPERATIVE REPORTS WERE RECEIVED. ENDOLEAK. EVALUATION: CONCLUSIONS: - LACK OF INFO, NO FILMS OR OPERATIVE REPORTS WERE RECEIVED. SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. VESSEL MORPHOLOGY WAS NON-TORTUOUS AND NON-CALCIFIED. IT WAS REPORTED UPON THE FINAL ANGIOGRAM RUN IT APPEARED AS THERE MIGHT BE A TYPE III ENDOLEAK NEAR THE FLOW DIVIDER IN THE IPSILATERAL LIMB. THE PHYSICIAN ELECTED TO BALLOON WITH ANOTHER MANUFACTURER'S BALLOON, IT WAS REPORTED THAT THE INFLATION OF THE BALLOON WAS AGGRESSIVE. THE LEAK WAS STILL VERY FOCAL, THE POSSIBLE ENDOLEAK WAS JUST BELOW THE FLOW DIVIDER AND THE PHYSICIAN ELECTED RELINE THE STENT GRAFT WITH TWO ILIAC LIMBS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT DELIVERY SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00043793Y

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention