BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRED 27

    MDR report key: 12729341 · Received November 1, 2021

    Report

    Report Number
    2032493-2021-00426
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    October 1, 2021
    Report Date
    October 4, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    UDI-DI
    04987892121845
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES STENT THROMBOSIS AS A POTENTIAL COMPLICATION ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FRED STENT WAS USED FOR THE TREATMENT OF A CEREBRAL ANEURYSM. AFTER IMPLANTATION, ANGIOGRAPHY REVELED A SMALL THROMBUS IN THE DISTAL PART OF THE IMPLANTED FRED AND EFFIENT WAS ADMINISTERED. SEVERAL ATTEMPTS WERE MADE TO ADDRESS THE THROMBUS USING BALLOONS AND ASPIRATION DEVICES WITHOUT SUCCESS, WHICH RESULTED IN THE IMPLANTED FRED TO BECOME SHORTENED TOWARDS THE DISTAL END AND MORE THROMBI WERE FORMED. AS NO IMPROVEMENT WAS MADE, THE PROCEDURE WAS CONCLUDED. THE PATIENT OUTCOME WAS DESCRIBED AS UNSPECIFIED SERIOUS HEALTH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630168 FRED 27 FLOW DIVERTER OUT MICROVENTION, INC. MV-F401227 20102856P 04987892121845

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R