BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LVIS D

    MDR report key: 20447611 · Received October 14, 2024

    Report

    Report Number
    2032493-2024-00759
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 14, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    QCA
    UDI-DI
    04987350609373
    PMA / PMN Number
    P170013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 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, STENT GOT STUCK IN THE MICROCATHETER. WHEN ATTEMPTING TO RECAPTURE THE STENT, THE STENT BECAME STUCK AND WAS UNABLE TO BE FULLY RETRACTED INTO THE MICROCATHETER. THE STENT WAS THEN WITHDRAWN TOGETHER WITH THE MICROCATHETER AND SUCCESSFULLY REMOVED FROM THE PATIENT. ANOTHER STENT WAS USED TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319388 LVIS D INTRACRANIAL COIL-ASSIST STENT QCA MICROVENTION, INC. MV-L452321 0000147144 04987350609373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other