BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1080775 · Received July 23, 2008

    Report

    Report Number
    2953200-2008-00591
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: - LACK OF INFO - NO FILMS AVAILABLE. EVALUATION: CONCLUSION: - LACK OF INFO - NO FILMS AVAILABLE. REQUIRED SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT AFTER ALL THE STENT GRAFTS WERE IMPLANTED THERE WAS A TYPE 3 ENDOLEAK COMING FROM BETWEEN 2 ILIAC STENT GRAFT COMPONENTS. THE AREA OF ENDOLEAK WAS AGGRESSIVELY BALLOONED WITH A RELIANT BALLOON. AFTER THE BALLOONING THE ENDOLEAK BECAME WORSE AND THE DECISION WAS MADE TO RELINE THE AREA OF LEAKING WITH ANOTHER ANEURX ILIAC STENT GRAFT. THE ENDOLEAK WAS COMPLETELY RESOLVED. NO FILMS FOR REVIEW OF THE CASE WERE PROVIDED. 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 SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00115780

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention