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	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Lava worked but the physician experienced difficulty in visualizing the lava under the fluoroscope.They stated it was less opaque than other embolic products they have previously used.
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 and it was learned that the patient was treated successfully.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.Review of manufacturing, testing, and inspection records confirmed that all acceptance criteria were met.Sirtex medical affairs stated the physician reported reduced fluoroscopic visualization of lava during delivery; however, the embolization procedure was completed successfully with no reported patient injury, non-target embolization, or adverse clinical sequelae.While inadequate visualization could potentially increase the risk of unintended embolic delivery, there is no evidence that such an outcome occurred in this case.Based on the available information, this event is assessed as a device performance complaint without associated patient harm and does not alter the overall benefit-risk profile of lava.

• Brand Name: LAVA-18, 2 ML
• Common Device Name: Embolization Agent, Vascular
• Manufacturer (Section D): SIRTEX MEDICAL, INC.; 300 unicorn park dr.; 2nd fl.; woburn MA 01801
• Manufacturer Contact: melissa sanchez ; 300 unicorn park drive; 2nd fl.; woburn, MA 01801
• MDR Report Key: 25394335
• Report Number: 9710358-2026-00016
• Device Sequence Number: 20134981
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: (01)00850055697003(17)280816(10)9000243
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 06/04/2026

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 Expiration Date: 08/16/2026
• Device Model Number: SLLES182
• Device Lot Number: 9000243
• 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: 05/06/2026
• Initial Report FDA Received Date: 06/04/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown