BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRED 27

    MDR report key: 12746023 · Received November 3, 2021

    Report

    Report Number
    2032493-2021-00430
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    October 1, 2021
    Report Date
    October 5, 2021
    Product Code
    OUT
    UDI-DI
    04987892121913
    PMA / PMN Number
    P180027
    Adverse Event
    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. NO PROCEDURE IMAGES PROVIDED. 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 · 0

    IT WAS REPORTED THAT THE FRED STENT WAS USED FOR TREATMENT OF AN ANEURYSM AT THE SIPHON OF THE LEFT INTERNAL CAROTID ARTERY (ICA). FOLLOW-UP ANGIOGRAPHY 3 MONTHS POST PROCEDURE REVEALED OCCLUSION AT THE SITE OF THE FRED STENT IMPLANTATION IN THE LEFT ICA. THE ANEURYSM WAS LESS THAN 2MM AND 5 COILS WERE IMPLANTED AFTER THE STENT IMPLANTATION. DUE TO VASCULAR ANATOMY, THE STENT WAS IMPLANTED IN A LESION THAT COULD ONLY BE DEPLOYED IN THE STRETCHED STATE. IN ADDITION, THE MIP IMAGE SHOWED THAT THERE WAS BONE ON THE PROXIMAL SIDE OF THE LESION. PTA WAS PERFORMED ON THE SAME DAY AND THE PHYSICIAN ASSUMES THAT THE PTA MIGHT HAVE CREATED A SPOT WHERE THE FRED FIRMLY APPOSED AND A SPOT WHERE IT WAS NOT FULLY DEPLOYED AND APPOSED DUE TO THE BONE. THE FRED STENT OPENED PROPERLY DURING IMPLANTATION; HOWEVER, IT WAS LIKELY THAT THERE WAS SOME PART THAT APPOSED TO VESSEL WALL AND SOME PART THAT DID NOT. THE PHYSICIAN ADVISED THAT THE PATIENT IS ASYMPTOMATIC AND NO ADDITIONAL TREATMENT IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643985 FRED 27 FLOW DIVERTER OUT MV-F452827 20010655U 04987892121913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention