BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SL

    MDR report key: 19935092 · Received August 7, 2024

    Report

    Report Number
    2032493-2024-00601
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    April 1, 2022
    Report Date
    August 7, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AND A LOT HISTORY TRENDING REVIEW COULD NOT BE PERFORMED. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES ANEURYSM RUPTURE AS POTENTIAL COMPLICATION ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, THIS WAS AN UNRUPTURED ANEURYSM IN A PATIENT THAT RUPTURED AFTER WEB PLACEMENT. CASE WAS A MCA BIFURCATION THAT HAPPENED IN APRIL 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2402785 WEB SL INTRASACCULAR DEVICES OPR MICROVENTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other