BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1822558 · Received August 27, 2010

    Report

    Report Number
    2953200-2010-01654
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: ENDOLEAK, UNK SOURCE OF ENDOLEAK. CONCLUSION: UNK SOURCE OF ENDOLEAK.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 8 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THERE IS AN ALLEGED PROXIMAL TYPE 1 ENDOLEAK PRESENT. AN ANGIOGRAM WAS PERFORMED TO CONFIRM THE ENDOLEAK AND TO PROVIDE INFORMATION FOR POTENTIAL TREATMENT. THE ANGIOGRAM DEMONSTRATED THAT THERE WAS NO ENDOLEAK PRESENT. NO ADDITIONAL 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 GALWAY NA V00375279

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention