BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 8361366 · Received February 22, 2019

    Report

    Report Number
    2953200-2019-00262
    Event Type
    Death
    Date Received
    February 22, 2019
    Date of Event
    December 4, 2018
    Report Date
    February 22, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: MIDTERM SINGLE-CENTER RESULTS OF ENDOVASCULAR ANEURYSM REPAIR WITH ADDITIONAL ENDOANCHORS. SEKUB R. GOUDEKETTING, JAN WILLE, DANIEL A.F, VAN DEN HEUVEL, JAN-ALBERT VOS, JEAN-PAUL P.M. DE VRIES. DEPARTMENT OF VASCULAR SURGERY, ST ANTONIUS HOSPITAL, NIEUWEGEIN, THE NETHERLANDS, MIRA INSTITUTE OF BIOMEDICAL TECHNOLOGY AND TECHNICAL MEDICINE, UNIVERSITY OF TWENTE, ENSCHEDE, THE NETHERLANDS DEPARTMENT OF INTERVENTIONAL RADIOLOGY, ST ANTONIUS HOSPITAL, NIEUWEGEIN, THE NETHERLANDS DEPARTMENT OF VASCULAR SURGERY, UNIVERSITY MEDICAL CENTRE GRONINGEN, THE NETHERLANDS, HTTPS://DOI.ORG/10.1177/1526602818816099. FOLLOW UP: AGAINST IFU DUE TO USE IN SHORT NECK ANATOMY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    HELI-FX GUIDE, APPLIER AND ENDOANCHORS WERE USED PROPHYLACTICALLY AND THERAPEUTICALLY IN THE ENDOVASCULAR TREATMENT OF PATIENTS IN CONJUNCTION WITH ENDURANT, VALIANT AND TALENT STENT GRAFTS. THE FOLLOWING ADVERSE EVENTS WERE NOTED; DEATH; DEATH DUE TO PNEUMOSEPSIS, CHF, MULTIORGAN FAILURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156948 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death