BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 7942618 · Received October 8, 2018

    Report

    Report Number
    2953200-2018-01430
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Date of Event
    June 30, 2018
    Report Date
    December 19, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; IN SITU ANTEGRADE LASER FENESTRATIONS DURING ENDOVASCULAR AORTIC REPAIR THOMAS LE HOUÉROU, DOMINIQUE FABRE, CARLOS G. ALONSO, PHILIPPE BRENOT, RYIAD BOURKAIB, CLAUDE ANGEL, MYRIAM AMSALLEM, STEPHAN HAULON EUR J VASC ENDOVASC SURG (2018) 56, 356E362 HTTPS://DOI.ORG/10.1016/J.EJVS.2018.05.014. EXACT DATE OF IMPLANT UNKNOWN. 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 STENT SYSTEMS WERE IMPLANTED IN A NUMBER OF PATIENTS DURING LASER FENESTRATIONS ENDOVASCULAR AORTIC REPAIR. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: ENDOLEAKS TYPE III, STENT MIGRATION (DISLOCATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784904 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention