BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPLEX COMPLEX

    MDR report key: 12973272 · Received December 9, 2021

    Report

    Report Number
    2032493-2021-00478
    Event Type
    Injury
    Date Received
    December 9, 2021
    Date of Event
    September 6, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    UDI-DI
    00816777028198
    PMA / PMN Number
    K050954
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL CLARIFICATION RECEIVED INDICATING THE COIL DID NOT DETACH AND WAS REMOVED, THEN THE PHYSICIAN USED AND PLACED A SOLITAIRE AB STENT TO COMPLETE THE CASE. ACCORDINGLY, THIS EVENT IS NO LONGER ASSESSED REPORTABLE BY MICROVENTION, INC.

    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. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES PREMATURE COIL DETACHMENT AS A POTENTIAL COMPLICATION ASSOCIATED WITH USE OF THE DEVICE.

    Description of Event or Problem · 0

    ADDITIONAL CLARIFICATION RECEIVED INDICATING THE COIL DID NOT DETACH AND WAS REMOVED, THEN THE PHYSICIAN USED AND PLACED A SOLITAIRE AB STENT TO COMPLETE THE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT, THE COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN USED A SNARE TO REMOVE THE COIL FROM THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869896 MICROPLEX COMPLEX EMBOLIZATION COIL HCG MICROVENTION, INC. 181231CC-V-CN 2005295V3 00816777028198

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention