BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1760961 · Received July 14, 2010

    Report

    Report Number
    2953200-2010-01308
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: MODERATE TO SEVERE VESSEL TORTUOSITY AND CALCIFICATION. STIFF WIRE NOT AVAILABLE DURING THE PROCEDURE. CONCLUSION: MODERATE TO SEVERE VESSEL TORTUOSITY AND CALCIFICATION. STIFF WIRE NOT AVAILABLE DURING THE PROCEDURE.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF A 4.4 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS MODERATE TO SEVERE TORTUOSITY AND MODERATE TO SEVERE CALCIFICATION. IT WAS REPORTED THAT THE FIRST ANEURX DEVICE COULD NOT BE ADVANCED TO THE INTENDED LANDING ZONE; A STIFF ENOUGH WIRE WAS NOT AVAILABLE AT THE TIME OF THE PROCEDURE IN ORDER TO STRAIGHTEN THE TORTUOUS VESSELS, AND THEREFORE, THE DEVICE KINKED DURING THE ADVANCEMENT ATTEMPT. THE DEVICE WAS REMOVED FROM THE PT AND DISCARDED BY THE USER FACILITY. THE PHYSICIAN THEN BALLOONED THE VESSEL AND INSERTED ANOTHER ANEURX DEVICE (MFR REPORT # 2953200-2010-01309), WHICH ALSO KINKED DURING THE ADVANCEMENT ATTEMPT. THE SECOND DEVICE WAS ALSO REMOVED FROM THE PT AND DISCARDED BY THE USER FACILITY. THE PROCEDURE WAS ABORTED AT THIS TIME. NO 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 V00479236

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR