BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRED 27

    MDR report key: 12662154 · Received October 19, 2021

    Report

    Report Number
    2032493-2021-00419
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 22, 2021
    Report Date
    September 22, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    UDI-DI
    04987892121890
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INOFORMATION: B5, H10. THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION, SO THE INVESTIGATION COULD NOT DETERMINE IF A CONDITION EXISTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. GIVEN THAT THE FRED USED WAS 4.5 MM IN DIAMETER (MV-F451327), AND THAT THE MAXIMAL VESSEL DIAMETER LISTED ABOVE IS 4.78 MM, THE FRED USED WAS UNDERSIZED. THIS LIKELY CAUSED MALAPPOSITION WHICH MAY BE THE CAUSE OF THE ALLEGED THROMBOSIS.

    Description of Event or Problem · 0

    THE VESSEL DIAMETER OF THE LESION WAS 3.72 - 4.78MM. ANEURYSM SIZE WAS 12.15MM, NECK 6.34MM.

    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 THROMBUS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF THE FRED STENT IN THE C2 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA), IN-STENT THROMBOSIS WAS OBSERVED 2 HOURS POST IMPLANTATION. ACCORDING TO THE PHYSICIAN, THE EFFECTIVENESS OF THE ANTIPLATELET AGENT WAS CHECKED WITH VERIFYNOW AND THE EFFECT WAS POOR THE DAY BEFORE THE PROCEDURE. CILOSTAZOL WAS ADDED AND CHANGED TO TAPT. 20MG OF OZAGREL NA WAS INJECTED INTRAARTERIALLY AND THEN OZAGREL NA WAS ADMINISTRATED INTRAVENOUSLY, AND THE THROMBUS DISSOLVED. THE PATIENT HAD NO NEUROLOGICAL SYMPTOMS AND WAS DISCHARGED. NO PLANS FOR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559086 FRED 27 FLOW DIVERTER OUT MICROVENTION, INC. MV-F451327 20111758F 04987892121890

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention