BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1601068 · Received February 10, 2010

    Report

    Report Number
    2953200-2010-00199
    Event Type
    Death
    Date Received
    February 10, 2010
    Date of Event
    January 10, 2010
    Report Date
    January 11, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): RESULTS: DEATH. THE CAUSE OF THE KINK IN THE STENT GRAFT IS UNK. CONCLUSION: THE CAUSE OF THE KINK IN THE STENT GRAFT IS UNK.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT DEVICE WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT WHEN THE STENT GRAFT WAS BEING DEPLOYED WITH THE USE OF A DIGITAL SUBTRACTION ANGIOGRAM, THE STENT GRAFT KINKED. THE CAUSE OF THE KINKING OF THE STENT GRAFT IS KNOWN. THE PHYSICIAN ELECTED TO PERFORM AN OPEN SURGERY REPAIR; HOWEVER, THE PATIENT EXPIRED AFTER THE OPEN SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM NONE MIH MEDTRONIC CARDIOVASCULAR NA V00292068

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death