BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1679042 · Received May 7, 2010

    Report

    Report Number
    2953200-2010-00806
    Event Type
    Death
    Date Received
    May 7, 2010
    Date of Event
    September 1, 2009
    Report Date
    April 9, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): RESULTS: (DEATH), (DISSEMINATED INTRAVASCULAR COAGULATION). CONCLUSIONS: (DISSEMINATED INTRAVASCULAR COAGULATION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROXIMATELY 9 MONTHS AGO. IT WAS REPORTED, THE PATIENT WAS IMPLANTED WITH 2 TALENT THORACIC STENT GRAFTS SUCCESSFULLY. THE PHYSICIAN ELECTED TO IMPLANT A 3RD THORACIC STENT GRAFT WHICH COVERED THE JUNCTION OF THE 2 OTHER DEVICES. IT WAS REPORTED THAT THE PATIENT EXPIRED ONE TO TWO WEEKS POST STENT GRAFT IMPLANT, DUE TO DIC (DISSEMINATED INTRAVASCULAR COAGULATION). THE PHYSICIAN STATED THAT THERE IS NO RELATIONSHIP BETWEEN THE DIC AND THE STENT GRAFT. NO FURTHER INFORMATION HAS BEEN PROVIDED FOR THIS CASE. (MFR REPORT #S 2953200-2010-00804, 2953200-2010-00805).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00312775

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death