BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO (US)

    MDR report key: 1413509 · Received July 2, 2009

    Report

    Report Number
    2953200-2009-00840
    Event Type
    Death
    Date Received
    July 2, 2009
    Date of Event
    June 2, 2009
    Report Date
    June 3, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES, RESULTS: (DEATH), CONCLUSION CODE: (MYOCARDIAL INFRACTION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT DEVICE WAS SUCCESSFULLY IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT TWO BIFURCATED STENT GRAFTS WERE IMPLANTED FOR A PLANNED AUI. THE DEVICES WERE SUCCESSFULLY IMPLANTED AND THE PATIENT WAS TAKEN TO THE ICU FOR RECOVERY. (MFR REPORT# 2952300-2009-00839). IT WAS REPORTED THAT WHILE THE PATIENT WAS IN THE ICU FOR RECOVERY, THE PATIENT HAD A MYOCARDIAL INFRACTION AND EXPIRED. THE PHYSICIAN STATED THAT THE STENT GRAFTS PERFORMED AS INTENDED AND THE PATIENT EXPIRING WAS NOT RELATED TO THE STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO (US) MIH MEDTRONIC CARDIOVASCULAR NA V00261542

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death