BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT NAVION

    MDR report key: 8649050 · Received May 29, 2019

    Report

    Report Number
    9612164-2019-02058
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 27, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILM ANALYSIS SUMMARY: THE EXACT CAUSE OF THE REPORTED RETROGRADE TYPE A DISSECTION REPORTED ~2 MONTHS POST-IMPLANT COULD NOT BE DETERMINED FROM THE PRE-IMPLANT FILM REPORT RETURNED. COMPLETE CT¿S PRIOR TO IMPLANT WERE NOT AVAILABLE AND A COMPREHENSIVE ANATOMY REVIEW COULD NOT BE COMPLETED. IMAGES DURING IMPLANT AND POST-IMPLANT WERE ALSO NOT AVAILABLE, AND THE REPORTED TYPE A DISSECTION AS WELL AS THE STENT GRAFT IN-VIVO POSITION AND CONFIGURATION COULD NOT BE ASSESSED. ANALYSIS OF THE RETURNED FILMS DID NOT REVEAL ANY ANATOMICAL CHARACTERISTICS THAT COULD EXPLAIN THE REPORTED DISSECTION. IT IS UNCLEAR IF THE REPORTED TYPE A DISSECTION WAS POSSIBLY PROCEDURE RELATED, DUE TO A PATIENT RELATED ISSUE, OR POSSIBLY CAUSED BY AN UNKNOWN INTERACTION WITH THE IMPLANTED STENT GRAFTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    UPDATE PMA# P100040. 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

    A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 66MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP CT TWO MONTHS LATER AND A RETROGRADE TYPE A DISSECTION WAS OBSERVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444498 VALIANT NAVION SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VNMF4640C185TE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening