BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEB

    MDR report key: 15890462 · Received November 30, 2022

    Report

    Report Number
    2032493-2022-00537
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    November 15, 2022
    Report Date
    November 15, 2022
    Manufacturer
    MICROVENTION, INC.
    Product Code
    OPR
    UDI-DI
    00842429110898
    PMA / PMN Number
    P170032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 DEVICE REMAINS WITHIN THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, THE WEB DID NOT DETACH FROM THE DELIVERY PUSHER. ADDITIONAL DETACHMENT CONTROLLERS WERE USED UNSUCCESSFULLY. THE DEVICES WERE REPORTED TO PASS THE PRIOR TO USE TESTING. THE WEB WAS MANIPULATED EXTENSIVELY AND WAS REPORTED TO MOVE, TILT WITHIN THE ANEURYSM. THE WEB DETACHED WITHIN THE ANEURYSM UNEXPECTEDLY HOWEVER, NOT IN ITS ORIGINAL POSITION. THE PATIENT WAS REPORTED TO BE RECOVERING WELL. NO SECONDARY INTERVENTION WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2697048 WEB INTRASACCULAR DEVICES OPR MICROVENTION, INC. W5-6-4-MVI-3 0000224734 00842429110898

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other