BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRED 27

    MDR report key: 12701266 · Received October 26, 2021

    Report

    Report Number
    2032493-2021-00425
    Event Type
    Injury
    Date Received
    October 26, 2021
    Report Date
    October 1, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    UDI-DI
    04987892121814
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 ANALYSIS; THEREFORE, THE ALLEGED PRODUCT 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 WAS IMPLANTED TO TREAT A LARGE THROMBOTIC ANEURYSM IN THE BASILAR ARTERY AND THERE WAS A TEMPORARY POSTOPERATIVE CEREBRAL EDEMA. NEUROLOGICAL SYMPTOMS WORSENED DUE TO TEMPORARY POSTOPERATIVE CEREBRAL EDEMA. HOWEVER, THE PATIENT HAS IMPROVED AND IS CURRENTLY UNDERGOING REHABILITATION. THE EVENT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598515 FRED 27 FLOW DIVERTER OUT MICROVENTION, INC. MV-F352427 20040654Y 04987892121814

    Patients

    Seq Age Sex Outcome Treatment
    1