BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRED X27

    MDR report key: 15795279 · Received November 14, 2022

    Report

    Report Number
    2032493-2022-00526
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    October 25, 2022
    Report Date
    November 14, 2022
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    UDI-DI
    00842429114490
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THE REPORTED PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS AND PROCEDURE IMAGES WERE NOT PROVIDED; THEREFORE, A PRODUCT ANALYSIS COULD NOT BE CONDUCTED, AND THE REPORTED ISSUE CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL ISSUE A SUPPLEMENTAL MDR REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FRED X STENT DID NOT OPPOSE COMPLETELY ON THE DISTAL PORTION OF THE WALL, AND THE MIDDLE SECTION OF THE STENT DID NOT FULLY OPEN. A BALLOON ANGIOPLASTY WAS PERFORMED ON BOTH THE DISTAL AND MIDDLE SEGMENT, AND THE MIDDLE SECTION OF THE STENT OPENED BETTER AS A RESULT. THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2773889 FRED X27 FLOW DIVERTER OUT MICROVENTION, INC. FREDX5532-PMA 0000155790 00842429114490

    Patients

    Seq Age Sex Outcome Treatment
    1 Female