BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1922618 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02198
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS SELECTED FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING PREPPING OF THE DEVICE, A KINK WAS NOTICED ABOUT 1/3 OF THE WAY DOWN FROM THE HANDLE TOWARDS THE TAPER TIP. IT IS UNK WHETHER THE KINK WAS DUE TO USER HANDLING OR WAS KINKED IN THE PACKAGING. THERE WAS DAMAGE TO THE OUTER PACKAGING OF THE DELIVERY CATHETER PRIOR TO PREPPING THE DEVICE. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE SUCCESSFULLY. 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 MIH MEDTRONIC CARDIOVASCULAR NA V00161152N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK