BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 24323106 · Received February 12, 2026

    Report

    Report Number
    9710358-2026-00001
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    January 13, 2026
    Report Date
    February 12, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    QVG
    UDI-DI
    00850055697003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING FILED FOR THE POTENTIAL OF SERIOUS INJURY AS THIS WAS AN EMERGENT CASE. THERE WAS NO REPORTED DEATH OR SERIOUS INJURY TO THE PATIENT. A BACKSTOCK OF DMSO WAS USED WHILE THE VIAL THAWED. STORAGE INSTRUCTIONS IN THE LAVA LES IFU STATE TO THAW THE PRODUCT AT ROOM TEMPERATURE IF IT SOLIDIFIES. SIRTEX ENGINEERING HAS STATED THE DESIGN VERIFICATION TESTING OF THE LAVA LES WAS PERFORMED ON LAVA VIALS THAT WERE SUBJECTED TO ENVIRONMENTAL CONDITIONING AND DISTRIBUTION TESTING PER ASTM F2825 AND ASTM AND MET ALL PERFORMANCE AND FUNCTIONAL REQUIREMENTS. DMSO, THE MAIN CONSTITUENT OF THE LIQUID EMBOLIC SOLUTION, HAS THE PHYSICAL PROPERTY OF FREEZING AT ABOUT 18.55DC (65.4DF). THE PRODUCT IS SHIPPED WITH 2-INCHES THICK INSULATION PLUS 3 PACKS OF 24 OZ GEL REFRIGERANT (GEL PACKS) PER INTERNAL SHIPPING PROCEDURES. A BATCH RECORD REVIEW WAS PERFORMED AND SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS WITH PASSING QUALITY TEST RESULTS AND WITH NO NONCONFORMITIES OR DEVIATIONS. SIRTEX MEDICAL AFFAIRS HAS STATED THIS EVENT APPEARS TO BE RELATED TO SHIPPING AND HANDLING RATHER THAN ANY ISSUE WITH DEVICE PERFORMANCE OR SAFETY. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL IMPACT, AND THE PROCEDURE WAS ABLE TO PROCEED AS PLANNED USING AVAILABLE DMSO WHILE THE DELIVERED VIAL THAWED. REVIEW OF THE DEVICE HISTORY RECORD FOR THE AFFECTED LOT DID NOT IDENTIFY ANY MANUFACTURING ISSUES, AND THIS EVENT DOES NOT CHANGE THE OVERALL SAFETY PROFILE OF LAVA-18.

    Description of Event or Problem · 0

    UPON DELIVERY, LAVA WAS NEEDED RIGHT AWAY. THE DMSO WAS FROZEN SOLID AND NEEDED TO BE THAWED, THEREFORE DELAYING THE CASE. EXTRA DMSO WAS AVAILABLE AND USED WHILE THE FROZEN DMSO THAWED. AN IMPROVEMENT SUGGESTION WAS OFFERED TO CHANGE THE SHIPPING CONTENTS TO GUARANTEE THAT NO PRODUCT IS FROZEN UPON ARRIVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218881 LAVA-18, 2 ML Embolization Agent, Vascular QVG SIRTEX MEDICAL, INC. SLLES182 10906 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown