BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SLS

    MDR report key: 22079668 · Received May 23, 2025

    Report

    Report Number
    2032493-2025-90183
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    February 11, 2025
    Report Date
    May 23, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    UDI-DI
    00842429107195
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AS IT REMAINS WITHIN THE PATIENT; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL MDR REPORT. 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.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY, EVENT #3. EVENT TERM: WEB COMPACTION, ADDITION OF STENT AND COIL. NO TECHNICAL EVENT REPORTED. THE RELATIONSHIP TO THE STUDY DEVICE IS REPORTED AS PROBABLE. RELATIONSHIP TO STUDY DISEASE IS REPORTED AS POSSIBLE. AE OUTCOME: RECOVERED/RESOLVED. DATE OF RESOLUTION: (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060167 WEB SLS INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC. W2-9-4-MVI-3 0000063596 00842429107195

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention