BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA - FF

    MDR report key: 4103277 · Received September 19, 2014

    Report

    Report Number
    2953200-2014-01881
    Event Type
    Death
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT THORACIC STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR AN EMERGENT TREATMENT OF A THORACIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT SUFFERED A STROKE POST IMPLANT. THREE WEEKS POST IMPLANT THE PATIENT EXPIRED DUE TO A TYPE A DISSECTION WITH CARDIAC TAMPONADE. IT WAS NOTED UPON AUTOPSY THAT THE PATIENT HAD AN ANTEROGRADE DISSECTION ORIGINATING FROM THE REGION WHERE THE BARE STENT LONGITUDINAL TOWARD THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581722 VALIANT CAPTIVIA - FF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04258361

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Death