BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 24561487 · Received March 10, 2026

    Report

    Report Number
    9710358-2026-00007
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 10, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    QVG
    UDI-DI
    00850055697003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY IF NON-TARGET EMBOLISM OCCURRED DUE TO THE LOSS OF VISUALIZATION OF THE LAVA. THE EVENT DID NOT INVOLVE DEATH OR SERIOUS INJURY. THE DEVICE LABELING (IFU) STATES ADEQUATE FLUOROSCOPIC VISUALIZATION MUST BE MAINTAINED DURING LAVA DELIVERY AND TO STOP LAVA DELIVERY IF VISUALIZATION IS LOST UNTIL ADEQUATE VISUALIZATION IS REESTABLISHED. MEDICAL AFFAIRS STATED THE REPORTED DIFFICULTY VISUALIZING LAVA UNDER FLUOROSCOPY DURING GDA EMBOLIZATION REPRESENTS A USER-EXPERIENCE AND PRODUCT PERFORMANCE CONCERN RATHER THAN A CONFIRMED DEVICE MALFUNCTION OR SAFETY EVENT. NO PATIENT HARM, ADVERSE CLINICAL OUTCOME, OR PROCEDURAL COMPLICATION WAS REPORTED. THE BATCH RECORD REVIEW SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS AND HAD PASSING QUALITY TEST RESULTS.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED DIFFICULTY VISUALIZING LAVA DURING DELIVERY WHILE PERFORMING A GASTRODUODENAL ARTERY (GDA) EMBOLIZATION. THE PHYSICIAN STATED THAT THE EMBOLIC AGENT WAS VERY DIFFICULT TO SEE UNDER FLUOROSCOPY DURING INJECTION, WHICH MADE HIM HESITANT AND UNCOMFORTABLE DURING DELIVERY. THE PHYSICIAN EXPRESSED CONCERN THAT LIMITED VISUALIZATION INCREASED PROCEDURAL UNCERTAINTY DURING EMBOLIZATION. NO DEVICE MALFUNCTION OR USER ERROR WAS IDENTIFIED OR REPORTED AT THE TIME OF THE PROCEDURE. THE PHYSICIAN SUGGESTED EVALUATING INCREASED RADIOPAQUE CONTENT (E.G., HIGHER TANTALUM CONCENTRATION) OR THE POTENTIAL AVAILABILITY OF AN OPTIONAL KIT THAT WOULD ALLOW ADDITIONAL TANTALUM POWDER TO BE ADDED TO LAVA TO IMPROVE VISUALIZATION DURING DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616772 LAVA-18, 2 ML Embolization Agent, Vascular QVG SIRTEX MEDICAL, INC. SLLES182 9000221 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown