BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SL

    MDR report key: 16381248 · Received February 15, 2023

    Report

    Report Number
    2032493-2023-00572
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    February 2, 2023
    Report Date
    February 2, 2023
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    UDI-DI
    00842429110881
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES THROMBUS AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TREATMENT OF AN ACOM ANEURYSM, THE WEB WAS DETACHED WITHOUT INCIDENT. AFTER DEPLOYMENT THE ACA IS PATENT WITH A SMALL CLOT IN THE VESSEL. AFTER 15 MINUTES, THE ACA CLOSED DUE TO THROMBOTIC EVENT. INTEGRILLIN WAS USED TO RE-OPEN THE ACA. THE PATIENT WAS REPORTED TO BE DOING GREAT. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968631 WEB SL INTRASACCULAR FLOW DISRUPTION DEVICE OPR MICROVENTION, INC. W5-6-3-MVI-3 0000249920 00842429110881

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention