BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-34, 6 ML

    MDR report key: 24715188 · Received March 30, 2026

    Report

    Report Number
    9710358-2026-00010
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 25, 2026
    Report Date
    March 27, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    QVG
    UDI-DI
    00850055697034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DID NOT INVOLVE DEATH OR SERIOUS INJURY AND IT WAS STATED THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 AND THE PROCEDURAL DELAY IN TRANSITIONING TO A DIFFERENT DEVICE. THE 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. THE BATCH RECORD REVIEW FOUND THE DEVICE TO BE MANUFACTURED IN ACCORDANCE WITH THE APPROVED SPECIFICATIONS. THE RADIOPACITY OF THE DEVICE IS DEPENDENT ON THE THE TANTALUM ADDED TO THE PRODUCT DURING MANUFACTURING AND TANTALUM AMOUNTS WERE FOUND TO BE WITHIN SPECIFICATION. THE INVESTIGATION IS ON-GOING AS THE CUSTOMER HAS STATED THEY WILL RETURN THE DEVICE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, SIRTEX MEDICAL AFFAIRS HAS STATED REDUCED VISUALIZATION MAY THEORETICALLY IMPACT EMBOLIC CONTROL AND INCREASE THE RISK OF NON-TARGET EMBOLIZATION; HOWEVER, THIS IS A KNOWN PROCEDURAL CONSIDERATION MITIGATED THROUGH STANDARD PRACTICE, INCLUDING FLUOROSCOPIC MONITORING AND CESSATION OF DELIVERY IF VISUALIZATION IS INADEQUATE. MANUFACTURING REVIEW CONFIRMED THE DEVICE MET ALL SPECIFICATIONS, AND NO DEVICE DEFICIENCY HAS BEEN IDENTIFIED. OVERALL, THIS REPRESENTS A DEVICE PERFORMANCE CONCERN WITHOUT PATIENT HARM, WITH LOW TO REMOTE RISK OF INJURY.

    Description of Event or Problem · 0

    THE PHYSICIAN WAS PERFORMING AN EVAR TYPE 2 ENDOLEAK PROCEDURE AND STATED THE LAVA 34 DID NOT HAVE ITS USUAL OPACITY AND WAS VERY HARD TO SEE. THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374162 LAVA-34, 6 ML Embolization Agent, Vascular QVG SIRTEX MEDICAL, INC. SLLES346 10892 00850055697034

    Patients

    Seq Age Sex Outcome Treatment
    1