MAUDE Adverse Event Report: SIRTEX MEDICAL, INC. LAVA-18, 2 ML; Embolization Agent, Vascular

Model Number	SLLES182
Medical Device Problem Codes	Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: LAVA-18, 2 ML
• Common Device Name: Embolization Agent, Vascular
• Manufacturer (Section D): SIRTEX MEDICAL, INC.; 300 unicorn park dr.; fl. 2; woburn MA 01801
• Manufacturer Contact: 300 unicorn park drive; fl. 2; woburn, MA 01801
• MDR Report Key: 24561487
• Report Number: 9710358-2026-00007
• Device Sequence Number: 18670657
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: (01)00850055697003(17)280816(10)9000221
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SLLES182
• Device Lot Number: 9000221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown