BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAVA-18, 2 ML

    MDR report key: 24445916 · Received February 25, 2026

    Report

    Report Number
    9710358-2026-00005
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    December 2, 2025
    Report Date
    April 20, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    QVG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIRTEX MEDICAL AFFAIRS HAS STATED BASED ON THE AVAILABLE INFORMATION, THIS CASE DESCRIBES A DIFFUSE URTICARIAL REACTION (HIVES) OCCURRING FOLLOWING LEFT OVARIAN VEIN EMBOLIZATION WITH THE LAVA LIQUID EMBOLIC SYSTEM. THE TEMPORAL ASSOCIATION SUGGESTS A POSSIBLE RELATIONSHIP TO THE PROCEDURE AND/OR DEVICE EXPOSURE; HOWEVER, CAUSALITY CANNOT BE DEFINITIVELY ESTABLISHED GIVEN THE LIMITED CLINICAL DETAILS AND LACK OF DEVICE-SPECIFIC INFORMATION (E.G., LOT NUMBER, FULL CONCOMITANT MEDICATION PROFILE). ALLERGIC OR HYPERSENSITIVITY REACTIONS TO EMBOLIC AGENTS ARE A KNOWN AND LABELED POTENTIAL COMPLICATION PER THE INSTRUCTIONS FOR USE. THE PATIENT'S PRIOR HISTORY OF ADHESIVE ALLERGY MAY INDICATE AN UNDERLYING PREDISPOSITION TO HYPERSENSITIVITY REACTIONS, REPRESENTING A PLAUSIBLE ALTERNATIVE CONTRIBUTING FACTOR. THERE IS NO EVIDENCE AT THIS TIME TO SUGGEST A DEVICE MALFUNCTION, QUALITY DEFECT, OR USE ERROR. THE EVENT IS THEREFORE ASSESSED AS POSSIBLY RELATED TO THE DEVICE, EXPECTED, AND CONSISTENT WITH THE KNOWN SAFETY PROFILE OF THE PRODUCT. SIRTEX MEDICAL, INC. HAS MADE MULTIPLE ATTEMPTS TO LEARN THE OUTCOME OF THE PATIENT AS WELL AS THE LOT NUMBER OF THE DEVICE. NO RESPONSE HAS BEEN RECEIVED. SHOULD AN UPDATE BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. SIRTEX MEDICAL HAS PROVIDED A LAVA SAMPLE FOR THE ALLERGIST AND IS ATTEMPTING TO OBTAIN AN UPDATE ON THE PATIENT.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED HIVES ALL OVER THEIR BODY SINCE UNDERGOING LEFT OVARIAN VEIN LAVA EMBOLIZATION. THE PATIENT WAS REFERRED TO AN ALLERGIST, WHO NEEDS A LAVA SAMPLE IN ORDER TO ARRANGE TESTING. PATIENT HAS HISTORY OF ALLERGY TO ADHESIVES AS THEIR ONLY ALLERGEN. PATIENT HAS HAD TO TAKE SEVERAL ROUNDS TO ORAL STEROIDS AND IS ON ANTIHISTAMINES CONSTANTLY.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED HIVES ALL OVER THEIR BODY SINCE UNDERGOING LEFT OVARIAN VEIN LAVA EMBOLIZATION. THE PATIENT WAS REFERRED TO AN ALLERGIST, WHO NEEDS A LAVA SAMPLE IN ORDER TO ARRANGE TESTING. PATIENT HAS HISTORY OF ALLERGY TO ADHESIVES AS THEIR ONLY ALLERGEN. PATIENT HAS HAD TO TAKE SEVERAL ROUNDS TO ORAL STEROIDS AND IS ON ANTIHISTAMINES CONSTANTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606605 LAVA-18, 2 ML EMBOLIZATION AGENT, VASCULAR QVG SIRTEX MEDICAL, INC. SLLES182

    Patients

    Seq Age Sex Outcome Treatment
    1