BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 4090585 · Received September 15, 2014

    Report

    Report Number
    2953200-2014-01834
    Event Type
    Death
    Date Received
    September 15, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER SUCCESSFUL IMPLANTATION OF THE VALIANT DEVICES, THE PATIENT CODED ON THE OPERATING TABLE AND EXPIRED. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570381 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04244289

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Death