BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SL

    MDR report key: 21370860 · Received February 12, 2025

    Report

    Report Number
    2032493-2025-00124
    Event Type
    Injury
    Date Received
    February 12, 2025
    Date of Event
    February 6, 2025
    Report Date
    February 12, 2025
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    UDI-DI
    00842429110928
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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 WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, THE ALLEGED PRODUCT ISSUE CANNOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL MDR REPORT.

    Description of Event or Problem · 0

    AS REPORTED THROUGH THE WEB PAS CLINICAL STUDY, SIGNIFICANT AMOUNT OF SACCULAR RECANALIZATION AND DEVICE COMPACTION REQUIRING RETREATMENT. A CAUSAL RELATIONSHIP TO THE STUDY DEVICE IS STATED. PATIENT HAD RT PROCEDURE ON (B)(6) 2025. NO AES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983678 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC. W5-7-3-MVI-3 0000309119 00842429110928

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention