BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROSOFT-3D-AV

    MDR report key: 20148013 · Received September 5, 2024

    Report

    Report Number
    2032493-2024-00663
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    August 28, 2024
    Report Date
    October 4, 2024
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    PMA / PMN Number
    K161452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS IMPLANTED IN THE PATIENT AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. PROCEDURAL OR MEDICAL IMAGING WAS NOT PROVIDED. THE ALLEGED PRODUCT ISSUE/EVENT AS DESCRIBED COULD NOT BE CONFIRMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, MICROVENTION, INC., WILL SUBMIT A SUPPLEMENTAL REPORT. THE INSTRUCTIONS FOR USE (IFU) IDENTIFIES COIL MIGRATION AS POTENTIAL COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE. 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.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BE SUBMITTED AS CLARIFYING INFORMATION RECEIVED INDICATED THAT THE COIL REFERENCED WAS NOT A MICROVENTION, INC. COIL, DEVICE. THEREFORE, MVI INC. NO LONGER CONSIDERS THIS EVENT A REPORTABLE EVENT.

    Description of Event or Problem · 0

    AS REPORTED, AFTER THE PATHWAY WAS ESTABLISHED, THE FIRST COIL WAS SELECTED. WHEN THE COIL WAS FILLED, THE COIL HERNIATED OUT OF THE ANEURYSM, A STENT WAS SELECTED. THE HEAD END OF THE STENT OPENED BUT COULD NOT BE APPOSITE TO THE WALL. THE NEW STENT WAS REPLACED, OPENED NORMALLY, AND THE REST OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED, "THE REPORTED COIL (3D 4*12) IS NOT MVI¿S PRODUCT, CAN¿T COLLECT THE COIL BRAND INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913210 HYDROSOFT-3D-AV VASCULAR EMBOLIZATION DEVICE HCG MICROVENTION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R