BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAVA-18, 2 ML

    MDR report key: 19259542 · Received May 7, 2024

    Report

    Report Number
    9710358-2024-00002
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 5, 2024
    Report Date
    May 7, 2024
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697003
    PMA / PMN Number
    P220020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF OUR REVIEW OF THE LOT HISTORY REPORT (LHR) SHOWED THAT THE PRODUCT MET THE PRODUCTION ACCEPTANCE CRITERIA PER ESTABLISHED MANUFACTURING PRODUCTION INSTRUCTIONS. THE RECORDS ALSO SHOW THAT THE SUB-ASSEMBLY PRODUCTION PARTS MET THE REQUIREMENTS AND SPECIFICATIONS PER ESTABLISHED MANUFACTURING REQUIREMENTS, SUCH AS STERILIZATION & VERIFICATION BY ANALYTICAL LABORATORY AND VISCOSITY MEASUREMENT. THE PRODUCT LOT PASSED VISUAL INSPECTIONS OF THE LES SERUM VIALS AND PASSED THE LEAK TEST.

    Description of Event or Problem · 0

    DOCTOR WAS ADMINISTERING DMSO/LAVA TO PATIENT. PATIENT WAS ON ANESTHESIA. DURING THE ADMINISTRATION PROCESS, ABOUT 20 MINUTES AFTER THE LAVA PRODUCT WAS ADMINISTERED, THE PATIENT EXPERIENCED A DROP IN HR AND BECAME STEMI. THE IR MD DOES NOT THINK THAT THE DMSO OR THE LAVA WERE CONTRIBUTORY TO THE DROP IN HR AND THE DROP SEEMED TO COINCIDE WITH THE ADMINISTRATION OF SOME HEPARIN TO THE PATIENT. HOWEVER, SINCE LAVA WAS BEING USED IN PROXIMITY TO THE DROP IN HR, THE DOCTOR COULD NOT RULE IT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530914 LAVA-18, 2 ML LAVA LIQUID EMBOLIC SYSTEM QVG BLACKSWAN VASCULAR, INC. SLLES182 10553 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other