BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 7685275 · Received July 13, 2018

    Report

    Report Number
    2953200-2018-01015
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    April 26, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; OPEN THORACIC AND THORACO-ABDOMINAL AORTIC REPAIR AFTER PRIOR ENDOVASCULAR THERAPY PAULA R. KESCHENAU, SHIRLEY KETTING, BAREND MEES, MOHAMMAD E. BARBATI, JOCHEN GROMMES, ALEXANDER GOMBERT, GEERT WILLEM H. SCHURINK, DROSOS KOTELIS, MICHAEL J. JACOBS EUR J VASC ENDOVASC SURG (2018) 56, 57-67, DOI.ORG/10.1016/J.EJVS.2018.03.015. 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 INTO PATIENTS FOR EVAR, TEVAR AND FEVAR TREATMENTS ON UNKNOWN DATES. THE LIST OF EVENTS THAT OCCURRED ARE THE FOLLOWING; MALFUNCTION; TYPE IA ENDOLEAK, TYPE IB ENDOLEAK, PERSISTING FALSE LUMEN PERFUSION, DEVICE FRACTURE/DISLOCATION AND INITIAL ENDOGRAFT MISPLACEMENT, MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527458 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR