BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2030428 · Received March 18, 2011

    Report

    Report Number
    2953200-2011-00679
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    February 17, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (GRAFT KINKING). (THROMBUS FROM THE PREVIOUS OPEN REPAIR). (LOT NUMBER AND ANATOMY DETAILS ARE UNK; OTHER MFR'S SYNTHETIC GRAFT MAY HAVE CONTRIBUTED TO EVENT). EVAL, CONCLUSIONS: (THROMBUS FROM THE PREVIOUS OPEN REPAIR). (LOT NUMBER AND ANATOMY DETAILS ARE UNK; OTHER MFR'S SYNTHETIC GRAFT MAY HAVE CONTRIBUTED TO EVENT).

    Description of Event or Problem · 1

    A TALENT CONVERTER STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON AN UNK DATE. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. A SYNTHETIC GRAFT HAD PREVIOUSLY BEEN IMPLANTED VIA AN OPEN REPAIR OVER 10 YEARS AGO. IT WAS REPORTED THAT THE TALENT CONVERTER (MFR# 2953200-2011-00680) WAS DEPLOYED WITHOUT ISSUES WITHIN THE PREVIOUSLY-PLACED SYNTHETIC GRAFT. HOWEVER, AFTER 5 MINUTES, NO FLOW WAS EVIDENT THROUGH THE DEVICE; THERE MAY HAVE BEEN A POTENTIAL LEAK IN THE SYNTHETIC GRAFT, WHICH MAY HAVE BEEN DUE TO LOOSE OR WEAK THROMBUS FROM THE PREVIOUS OPEN REPAIR. THE PHYSICIAN ELECTED TO RELINE THE TALENT CONVERTER WITH AN ANEURX LIMB; HOWEVER, THE GRAFT HAD A PINCH POINT. BASED ON A MEASUREMENT OF THE PRESSURE GRADIENT, THE PHYSICIAN WAS NOT CONCERNED AND THEREFORE, BALLOONED THE GRAFT AND THEN CLOSED THE PT. IT WAS THEN NOTED THAT THE PT'S LEFT LEG WAS MOTTLED AND COLD, THE PT WAS REOPENED. THE ANEURX GRAFT WAS THEN STENTED, SUCCESSFULLY RESTORING FLOW. 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 IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention