BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAVA-18, 6 ML

    MDR report key: 22669055 · Received July 30, 2025

    Report

    Report Number
    3005579300-2025-00004
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    September 18, 2024
    Report Date
    July 30, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A NEW REVIEW OF THIS EVENT WAS PERFORMED. A RETROSPECTIVE MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY. THE CUSTOMER DESCRIBED LAVA 18 APPEARED IN THE IMA AFTER THE ENDOLEAK WAS FILLED. THE PATIENT WAS ADMITTED FOR OBSERVATION FOR THE POSSIBILITY OF SMALL BOWEL ISCHEMIA. ISCHEMIA IS A POTENTIAL COMPLICATION DESCRIBED IN THE IFU AS WELL AS NON-TARGET VESSEL EMBOLIZATION. FOLLOW UP REQUEST FOR INFORMATION ON THE PATIENT STATUS WERE SENT. NO ADDITIONAL PATIENT INFORMATION WAS RECEIVED SINCE HOSPITAL ASKED NOT TO BE CONTACTED. BATCH RECORD REVIEW SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS AND HAD PASSING QUALITY TEST RESULTS.

    Description of Event or Problem · 0

    DURING EMBOLIZATION PROCEDURE, LAVA 18 APPEARED IN THE IMA AFTER THE ENDOLEAK WAS FILLED. PATIENT ADMITTED FOR RISK OF SMALL BOWEL ISCHEMIA. THE PATIENT WAS ADMITTED FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497431 LAVA-18, 6 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES186 10757 00850055697027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown