BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA STENT GRAFT

    MDR report key: 2172709 · Received July 20, 2011

    Report

    Report Number
    2953200-2011-01301
    Event Type
    Death
    Date Received
    July 20, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (DISSECTION; DEATH). EVALUATION, CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A 46MM VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM TWO MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS LITTLE TO NO VESSEL TORTUOSITY OR CALCIUM IN EITHER THE ILIACS OR THE AORTA. IT WAS REPORTED THAT THE INDEX PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. THE PT WAS UP EATING AND TALKING, ETC. FOR 8 HOURS POST OPERATIVELY, THE DAY OF THE PROCEDURE AND THEN SUDDENLY EXPIRED WITH NO SYMPTOMS OR CHANGES IN VITAL SIGNS. THE AUTOPSY REPORT STATES THAT THE CAUSE OF DEATH WAS DUE TO A RETROGRADE TYPE A DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALIANT CAPTIVIA STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00542281

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death