BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX BIFURCATED STENT GRAFT

    MDR report key: 2181389 · Received July 21, 2011

    Report

    Report Number
    2953200-2011-01308
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (INACCURATE PLACEMENT OF THE STENT GRAFT; ENDOLEAK). RESULTS/CONCLUSION: (DEVICE SLIPPED DURING CANNULATION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.1 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS NO TORTUOSITY AND A SMALL AMOUNT OF CALCIFICATION. IT WAS REPORTED THAT THE ANEURX MAIN BODY WAS DEPLOYED AT THE LEVEL OF THE RENALS. WHILE THE PHYSICIAN WAS ATTEMPTING TO CANNULATE THE CONTRALATERAL GATE, THE MAIN BODY SLIPPED OUT OF THE PROXIMAL SEAL ZONE. THE DISPLACEMENT RESULTED IN A TYPE 1A ENDOLEAK AND AN UNINTENTIONAL COVERAGE OF THE RIGHT HYPOGASTRIC ARTERY. THE TYPE 1A ENDOLEAK WAS RESOLVED WITH THE USE OF AN ENDURANT AORTIC EXTENSION ((B)(4)/LOT V00556561). THE FINAL RESULT WAS EXCLUSION OF THE ANEURYSM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX BIFURCATED STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00463924

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention