BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SL

    MDR report key: 24480333 · Received March 2, 2026

    Report

    Report Number
    2032493-2026-00143
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    February 5, 2026
    Report Date
    May 4, 2026
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS 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 RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WEB SL COULDN'T PASS THROUGH ITS MICROCATHETERS. WE MADE TWO ATTEMPTS, ONE WITH HEADWAY 17 AND ONE WITH A VIA 17. BOTH OF THEM FAILED AND WE STOPPED PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ENDOVASCULAR TREATMENT WAS SUSPENDED BECAUSE THERE WAS NO WAY TO USE THE APPROPRIATE WEB (SINCE IT DOES NOT PASS THROUGH THE MICROCATHETER). THE SUITABLE SIZE WAS THE 6X2, THE ANEURYSM WAS SHALLOW, NO WAY TO USE ANOTHER SIZE. THE PATIENT WAS TRANSFERRED TO THE SURGERY ROOM AND WAS TREATED SUCCESSFULLY. THE PATIENT HAS NOT BEEN TREATED YET AND THE CASE WAS NOT AN ACUTE CASE. THE TEAM HAD CONCERNS ABOUT THE BEST APPROACH, EVEN BEFORE THE TREATMENT, SINCE THE CASE IS NOT AN EASY ONE, FOR THE VASCULAR ARCHITECTURE. THE PATIENT IS FINE AND WILL UNDERGO CLIPPING SURGERY. BASED ON THE CLARIFICATION RECEIVED THIS EVENT IS BEING REPORTED DUE TO A PROLONGATION OF PROCEDURE AND POSTPONEMENT OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340499 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC. W5-6-2-MVI-MDR 0001451818

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Hospitalization| O MC172150SX, LOT NO. 0001352673.| VIA-17-154-01, LOT NO. 0001085804.