MAUDE Adverse Event Report: SIRTEX MEDICAL, INC. LAVA-34, 2 ML; Embolization Agent, Vascular

Model Number	SLLES342
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2026
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.Review of the batch record showed the device was manufactured to released specifications and had passing quality test results.Sirtex medical affairs has reviewed the case and has stated the reported event describes reduced visualization of lava during administration, with no patient harm and successful completion of the procedure.There is no evidence of clinical impact, and this is not an adverse event, but a device-related performance issue.The relationship to the device is related, and the event is not serious.Given the potential risk of non-target embolization if visualization is inadequate, the event is considered reportable as a malfunction and expected per ifu guidance requiring maintained visualization during delivery.
Event or Problem Description
The physician stated they had difficulty seeing the lava during administration but the procedure was successfully completed.

• Brand Name: LAVA-34, 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: 25073699
• Report Number: 9710358-2026-00014
• Device Sequence Number: 10306409
• Product Code: QVG
• UDI-Device Identifier: 00850055697027
• UDI-Public: (01)00850055697027(17)280816(10)0009000221
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/04/2026

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 Model Number: SLLES342
• Device Lot Number: 0009000221
• 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: 04/06/2026
• Initial Report FDA Received Date: 05/04/2026
• 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