BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 1822740 · Received August 26, 2010

    Report

    Report Number
    2953200-2010-01634
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK), (VESSEL MORPHOLOGY WAS NOT REPORTED). CONCLUSIONS: (VESSEL MORPHOLOGY WAS NOT REPORTED).

    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 ON AN UNKNOWN DATE. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. ON AN UNKNOWN DATE POST STENT GRAFT IMPLANT THE ANEURYSM WAS 5.5 CM IN DIAMETER. THE PATIENT RETURNED FOR A ROUTINE FOLLOW-UP ONE MONTH AGO, AND THE ANEURYSM MEASURED 8 CM IN DIAMETER WITH A PROXIMAL TYPE I LEAK PRESENT. THE PHYSICIAN ELECTED TO CONVERT THE DEVICE TO AN AUI. A TALENT CONVERTER WAS PLACED UP THE RIGHT SIDE ALONG WITH A PALMAZ STENT, AND THE LEFT SIDE WAS OCCLUDED WITH A TALENT OCCLUDER. THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. A FEMORAL TO FEMORAL BYPASS WAS PERFORMED SUCCESSFULLY. THERE WAS A TYPE IV ENDOLEAK THAT WAS PRESENT THROUGH THE CONVERTER AND STILL FILLED THE ANEURYSM SAC. NO ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WILL BE MONITORED IN A FEW MONTHS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention