BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM HYDRO

    MDR report key: 1211078 · Received October 24, 2008

    Report

    Report Number
    2953200-2008-00967
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: OTHER (TAPERED TIP/DELIVERY CATHETER) OTHER (DEVICE DISCARDED UNABLE TO EVALUATE).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT THE PHYSICIAN WAS INITIALLY UNABLE TO REMOVE THE PROXIMAL PORTION OF THE DELIVERY SYSTEM FROM THE BODY. IT APPEARED AS THOUGH THE NOSE CONE WAS CAUGHT IN THE IPSILATERAL LIMB. THE PHYSICIAN WAS ABLE TO MANEUVER THE DELIVERY SYSTEM BY ADVANCING AND RETRACTING THE NOSE CONE AND WAS ABLE TO REMOVE OF THE DELIVERY CATHETER. THE DEVICE WAS DISCARDED BY THE USER FACILITY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00164638

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK