BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3851115 · Received June 5, 2014

    Report

    Report Number
    2953200-2014-01131
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 200MM DESCENDING DISSECTION. IT WAS REPORTED THAT THE PATIENT SUFFERED AND EMBOLIC EVENT AND EXPIRED THE NEXT DAY. THE PHYSICIAN STATED THE EVENT WAS NOT STENT GRAFT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329636 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01719584

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Death