BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRED 21

    MDR report key: 11943493 · Received June 4, 2021

    Report

    Report Number
    2032493-2021-00219
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 4, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    UDI-DI
    00842429106587
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IMPLANTED IN THE PATIENT AND NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. POST PROCEDURAL IMAGES WERE NOT PROVIDED; THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. 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 INSTRUCTIONS FOR USE (IFU) IDENTIFIES HEMIPLEGIA, ISCHEMIC STROKE AND STENT THROMBOSIS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FRED JR. STENT WAS IMPLANTED TO TREAT AN ANEURYSM OF THE FETAL POSTERIOR CEREBRAL ARTERY. THE STENT WAS DEPLOYED WITHOUT ISSUE AND STASIS WAS OBSERVED TO BE FORMING INSIDE OF THE ANEURYSM. FOUR HOURS POST PROCEDURE, THROMBUS WAS OBSERVED TO BE FORMING INSIDE OF THE STENT. BALLOON ANGIOPLASTY WAS PERFORMED, WHICH RESTORED FLOW, BUT THE STENT CONTINUED TO FORM THROMBUS. IT WAS THE PHYSICIAN'S BELIEF THAT THE CLOT FORMATION INSIDE THE ANEURYSMAL SAC WAS SO SEVERE THAT IT WENT DOWN INTO THE FRED JR. A FOLLOW-UP THE NEXT DAY SHOWED RE-PROFUSION, BUT THE PATIENT HAD ALREADY HAD A STROKE AND THEY WERE BLIND ON RIGHT SIDE. INTEGRILIN WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838796 FRED 21 FLOW DIVERTER OUT MICROVENTION, INC. FRED2513-PMA 201007563 00842429106587

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S