BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1933717 · Received December 16, 2010

    Report

    Report Number
    2953200-2010-02576
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS & CONCLUSION: (NARROW AND SEVERELY CALCIFIED ACCESS VESSELS).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYS WAS INSERTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF A 64.9 CM ABDOMINAL AORTIC ANEURYSM. THE ACCESS VESSELS WERE NARROW MEASURING 6.8 MM ON THE LEFT AND 8.2 MM ON THE RIGHT AND THEY WERE SEVERELY CALCIFIED. IT WAS REPORTED THAT AFTER SERIAL DILATATION OF THE ACCESS VESSELS, THE DEVICE COULD NOT BE ADVANCED DUE TO THE NARROW, CALCIFIED VESSELS. THE DEVICE WAS REMOVED, AND A KINK IN THE DELIVERY SYS WAS NOTICED. ANOTHER TALENT DEVICE WAS INSERTED AND WAS ABLE TO BE ADVANCED AND SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE DEVICE WAS DISCARDED BY THE USER FACILITY. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00561285

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR