BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEB SL

    MDR report key: 24990845 · Received April 24, 2026

    Report

    Report Number
    2032493-2026-00280
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    April 16, 2026
    Report Date
    April 24, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OUT
    UDI-DI
    00842429103814
    PMA / PMN Number
    P170032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 IS REPORTED AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS. AT THIS TIME THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES NON-DETACHMENT, DIFFICULT OR DELAYED SEPARATION OF THE WEB AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, OPERATOR STATES THAT WEB FAILED TO DETACH AND WHEN TRIED TO RETRIEVE IT BACK INTO THE VIA MICROCATHETER, IT DEPLOYED INSIDE THE VIA INSTEAD. NO HARM CAUSED. NEW WEB IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600390 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OUT MICROVENTION, INC. W5-6-3-MVI-2 0001260014 00842429103814

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other VIA MICROCATHETER.