BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 8526188 · Received April 18, 2019

    Report

    Report Number
    2953200-2019-00524
    Event Type
    Death
    Date Received
    April 18, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 18, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; LATE COMPLICATIONS AFTER HYBRID AORTIC ARCH REPAIR. HYUN-CHEL JOO, YOUNG-NAM YOUN, JOON HO KWON, JONG YUN WON, DO YUN LEE, YOUNG-GUK KO, DONGHOON CHOI AND KYUNG-JONG YOO. J VASC SURG 2019 10.1016/J.JVS.2019.01.058. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR HYBRID ENDOVASCULAR TREATMENT OF THORACIC AORTIC ANEURYSMS AND TYPE B AORTIC DISSECTIONS INVOLVING THE DISTAL ARCH, AND ARCH ULCER/INTRAMURAL HEMATOMA. THE FOLLOWING EVENTS WERE REPORTED: DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320671 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death