BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3123096 · Received May 21, 2013

    Report

    Report Number
    2953200-2013-00946
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    May 14, 2012
    Report Date
    April 25, 2013
    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), RESULTS: INHERENT RISK OF PROCEDURE (DEATH). LACK OF INFORMATION (UNKNOWN CAUSE OF DEATH). (B)(4).

    Description of Event or Problem · 1

    A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION UNDER (B)(6). ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT DIED FIVE WEEKS AFTER THE PROCEDURE. THE PATIENT DIED AT HOME FROM AN UNKNOWN CAUSE. THIS PATIENT HAD AN UNEVENTFUL TEVAR FOR A CHRONIC DISSECTION. POST PROCEDURE IMAGING REVEALED SUCCESSFUL REPAIR OF THE DISSECTION; HOWEVER, THE PATIENT¿S HOSPITAL STAY WAS PROLONGED DUE TO DIFFICULTIES IN GETTING THE PATIENT EXTUBATED AND BY THE CONDITION OF THE PATIENT FEELING WEAK FROM THE HOSPITAL STAY. THE PATIENT WAS SENT HOME IN GOOD CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS EVENT. NO CLINICAL SEQUELAE WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223457 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death