BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA - CW

    MDR report key: 4800435 · Received May 27, 2015

    Report

    Report Number
    9612164-2015-00792
    Event Type
    Death
    Date Received
    May 27, 2015
    Date of Event
    January 1, 2014
    Report Date
    May 1, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF DEATH IS UNKNOWN. EXACT DATE OF EVENT IS UNKNOWN. EXACT DATE OF IMPLANT IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THIS EVENT IS BEING REPORTED AS PART OF A BULK DATA RELEASE PROVIDED TO MEDTRONIC FROM THE SOCIETY FOR VASCULAR SURGERY - PATIENT SAFETY ORGANIZATION TEVAR DISSECTION SURVEILLANCE INITIATIVE. THIS DATA HAS BEEN PROVIDED TO MEDTRONIC BY A THIRD PARTY (M2S) AND IS LIMITED AND DE-IDENTIFIED. ON AN UNKNOWN DATE IN 2014, A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE TREATMENT OF A THORACIC AORTIC DISSECTION. THE FOLLOWING ADVERSE EVENTS AND DEVICE MALFUNCTIONS WERE OBSERVED: HEMATOMA AT ACCESS SIGHT, ANEURYSM ENLARGEMENT, DEATH. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342669 VALIANT CAPTIVIA - CW SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMC4040C150TU

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death