BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2210581 · Received August 10, 2011

    Report

    Report Number
    2953200-2011-01423
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: ENDOLEAK. RESULTS/CONCLUSIONS: (UNK CAUSE OF ENDOLEAK).

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT AFTER THE ENDURANT BIFURCATED STENT GRAFT (MFR REPORT# 2953200-2011-01422) WAS IMPLANTED BELOW THE RENAL ARTERIES, A BLUSH WAS SEEN ON THE FINAL ANGIOGRAM RUN, WHICH WAS THOUGHT TO BE A TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ANEURX CUFF PROXIMALLY (MFR REPORT# 2953200-2011-01423); HOWEVER, THE SAME ENDOLEAK WAS STILL PRESENT. A STENT FROM ANOTHER MANUFACTURER WAS THEN PLACED; HOWEVER, THE SAME ENDOLEAK WAS STILL EVIDENT. AT THIS POINT, THE PHYSICIAN THOUGHT THE ENDOLEAK MIGHT BE A TYPE IV ENDOLEAK. NO FURTHER INTERVENTION WAS PERFORMED, AND THE PT WILL BE MONITORED. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention