BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT

    MDR report key: 4153222 · Received October 8, 2014

    Report

    Report Number
    2953200-2014-02010
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTIC 20 CM IN LENGTH DISSECTION. VESSEL MORPHOLOGY AT TIME OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WOKE UP IN THE ROOM AND WAS ABLE TO MOVE AROUND JUST FINE, THE PATIENT WAS TRANSFERRED TO THE UNIT AND AGAIN THE PATIENT WAS ABLE TO MOVE ALL FOUR EXTREMITIES JUST FINE. HOWEVER, THE NEXT DAY, WHEN THE PATIENT WAS TAKEN OFF THE VENTILATOR THEY HAD A STROKE AND WERE NOT ABLE TO MOVE THEIR LEFT SIDE. THE PHYSICIAN STATED THAT THE PROGNOSIS LOOKS GOOD AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS RECOVERING. THE GRAFTS WERE PLACED FROM THE SUBCLAVIAN TO ABOUT 4CM ABOVE THE CELIAC. THE ONLY THING THAT COULD HAVE CAUSED THE BLOOD CLOT FROM A PROCEDURE STAND POINT IS A WIRE DISLODGING A PIECE OF BLOOD CLOT. SINCE THE PATIENT WOKE UP AND MOVED EVERYTHING THE PHYSICIAN CANNOT DETERMINE THE CAUSE OF THE STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631246 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04087851

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR