BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT

    MDR report key: 24610312 · Received March 16, 2026

    Report

    Report Number
    2032493-2026-00166
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    February 21, 2026
    Report Date
    April 8, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    UDI-DI
    00842429114360
    PMA / PMN Number
    P180027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR RETURN. MEDICAL IMAGES WERE PROVIDED FOR REVIEW, THE INVESTIGATION OF WHICH IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FLOW DIVERTER STENT WAS USED TO TREAT A PATIENT WITH MALFORMATION IN PROXIMAL ICA MEASURING 3.0MM DISTAL, AND 3.52MM PROXIMAL. THE PATIENT STAYED IN THE HOSPITAL FOR FOUR DAYS DUE TO HEADACHE, WHEN DISCHARGED ON (B)(6) 2026. REPORTEDLY, FIVE DAYS POST DISCHARGE - THE PATIENT CAME BACK WITH HEADACHE AND LEFT SIDE WEAKNESS. DIGITAL SUBTRACTION ANGIOGRAPHY WAS PERFORMED AND THROMBECTOMY WAS ATTEMPTED ON (B)(6), 2026 BUT FAILED AS IT "COULD NOT GET THROUGH WITH WIRE." BREILENTA P2612 - 14 AND P2Y12 - 55 TRIPLE THERAPY WAS ADMINISTERED AND THE CASE COMPLETED SUCCESSFULLY. PATIENT OUTCOME REPORTED AS "TRIPLE THERAPY WITH NO COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255536 STENT INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICROVENTION, INC. FREDX4023-PMA 0000718671 00842429114360

    Patients

    Seq Age Sex Outcome Treatment
    1