BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 9489434 · Received December 18, 2019

    Report

    Report Number
    9612164-2019-05224
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    June 26, 2019
    Report Date
    December 18, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; HOMEMADE FENESTRATED STENT-GRAFTS FOR COMPLETE ENDOVASCULAR REPAIR OF AORTIC ARCH DISSECTIONS LUDOVIC CANAUD, BARIS ATA OZDEMIR, CHASSIN-TRUBERT, JULIEN SFEIR, PIERRE ALRIC AND THOMAS GANDET JOURNAL OF ENDOVASCULAR THERAPY, 2019, 26(5), HTTPS://DOI.ORG/10.1177/1526602819858578. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE THORACIC ENDOVASCULAR ANEURYSM REPAIR OF AORTIC ARCH DISSECTIONS. THE FOLLOWING EVENTS WERE REPORTED- MALFUNCTION: TYPE IA ENDOLEAK TYPE IB ENDOLEAK TYPE III ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282969 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR