BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAVA-18, 6 ML

    MDR report key: 25073322 · Received May 4, 2026

    Report

    Report Number
    9710358-2026-00013
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 3, 2026
    Report Date
    May 4, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    QVG
    UDI-DI
    00850055697027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING FILED AS SERIOUS INJURY TO THE PATIENT OCCURRED DURING A PROCEDURE WHERE ONE OF THE DEVICES USED WAS LAVA-18. THE REVIEW OF THE BATCH RECORD AND ASSOCIATED COMPONENT LOTS FOUND THAT THE LAVA-18 DEVICE DID NOT DISPLAY ANY ABNORMAL FINDINGS FOR THE MANUFACTURING PROCESS. THE LAVA IFU STATES TO USE MICROCATHETERS THAT ARE DMSO COMPATIBLE. DURING THE INVESTIGATION, IT WAS LEARNED THAT THE TERUMO PROGREAT LAMBDA CATHETER (175CM) MICROCATHETER IFU STATES ORGANIC SOLVENTS MAY CAUSE DAMAGE TO THE MIRCOCATHETER. ADDITIONALLY, T2 ENDOLEAK IS NOT LISTED ON THE LAVA IFU. SIRTEX HAS FOLLOWED UP WITH THE FACILITY AND HAS LEARNED THE PATIENT IS DOING WELL AND THAT NO SURGICAL INTERVENTION WAS NEEDED. SIRTEX MEDICAL AFFAIRS HAS REVIEWED THE CASE AND HAS STATED THE REPORTED EVENT DESCRIBES INCREASED INJECTION RESISTANCE WITH UNINTENDED LAVA DELIVERY, IN THE SETTING OF USE FOR A T2 ENDOLEAK AND WITH A MICROCATHETER THAT MAY NOT BE DMSO-COMPATIBLE, BOTH OUTSIDE IFU RECOMMENDATIONS. THIS REPRESENTS A SERIOUS ADVERSE EVENT, WITH FINDINGS MOST CONSISTENT WITH A CATHETER-RELATED ISSUE (E.G., INCOMPATIBILITY OR RUPTURE). THE IFU SPECIFICALLY WARNS TO USE DMSO-COMPATIBLE MICROCATHETERS AND TO STOP INJECTION IF RESISTANCE IS ENCOUNTERED, AS EXCESSIVE PRESSURE MAY RESULT IN CATHETER DAMAGE AND UNINTENDED EMBOLIZATION. THE RELATIONSHIP TO LAVA IS ASSESSED AS POSSIBLY RELATED IN THE CONTEXT OF USE, BUT MORE DIRECTLY ATTRIBUTABLE TO OFF-LABEL USE CONDITIONS AND DEVICE-USER INTERFACE FACTORS. THE EVENT IS EXPECTED, GIVEN KNOWN RISKS OUTLINED IN THE IFU.

    Description of Event or Problem · 0

    A PHYSICIAN EXPERIENCED PRESSURE IN THE SYRINGE WHILE DELIVERING LAVA-18 FOR A T2 ENDOLEAK USING A TERUMO PROGREAT LAMBDA CATHETER (175CM). THE PHYSICIAN STATED THE PRESSURE WAS NOT ALLOWING THEM TO DELIVER THE LAVA BUT CONTINUED WITH THE PROCEDURE WHEN THE PRESSURE RESOLVED. UPON VIEWING THE ANGIO SCREEN, THE LAVA WAS SEEN LOWER/INFERIOR TO WHERE THE CATHETER TIP WAS LOCATED NEAR THE ENDOLEAK. THE DECISION WAS MADE TO STOP ADMINISTRATION, AND TO REMOVE THE CATHETER. A HOLE ON THE CATHETER WAS DISCOVERED. IT WAS UNKNOWN IF THE HOLE WAS PRESENT BEFORE THE PROCEDURE. THE PHYSICIAN PERFORMED A PERCUTANEOUS STICK USING LAVA-18 WHICH SUCCESSFULLY TREATED THE ENDOLEAK. IT WAS STATED THAT THERE WAS A POTENTIAL FOR ISCHEMIA IN THE BOWEL AND THE PATIENT WAS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81338 LAVA-18, 6 ML Embolization Agent, Vascular QVG SIRTEX MEDICAL, INC. SLLES186 10946 00850055697027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown