BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 7792410 · Received August 17, 2018

    Report

    Report Number
    2953200-2018-01178
    Event Type
    Malfunction
    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
    Product Problem
    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: MALFUNCTION; UNKNOWN ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633915 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR