BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1891203 · Received October 29, 2010

    Report

    Report Number
    2953200-2010-02084
    Event Type
    Death
    Date Received
    October 29, 2010
    Date of Event
    September 27, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: DEATH, BLOOD PRESSURE FLUCTUATIONS DUE TO A TYPE II ENDOLEAK. CONCLUSION: BLOOD PRESSURE FLUCTUATIONS DUE TO A TYPE II ENDOLEAK.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE UNREMARKABLE. IT WAS REPORTED THAT THE STENT GRAFT WAS BALLOONED IN THE AORTIC BIFURCATION, WITH THE BALLOON MAINTAINED WITHIN THE STENT GRAFT AT ALL TIMES. THERE WERE FLUCTUATIONS IN THE PT'S BLOOD PRESSURE, WHICH WERE LIKELY DUE TO A TYPE II ENDOLEAK, BUT THERE WERE NO REPORTED STENT GRAFT-RELATED ISSUES. THE PT EXPIRED SOME TIME AFTER THE PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death