BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 7792601 · Received August 17, 2018

    Report

    Report Number
    2953200-2018-01179
    Event Type
    Death
    Date Received
    August 17, 2018
    Date of Event
    January 1, 2017
    Report Date
    February 8, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; SHORT-TERM AND LONG-TERM EFFECTS OF COVERED STENT ENDOVASCULAR GRAFT EXCLUSION FOR THE TREATMENT OF ABDOMINAL AORTIC ANEURYSM RUPTURE. L. LI, Y.Q. LI, B. LIU, H. WANG, D.M. ZHANG. EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES 2017; 21 (3 SUPPL): 73-77. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT CAPTIVIA STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF RUPTURED ABDOMINAL AORTIC ANEURYSMS. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633846 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death