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

Model Number	SLLES182
Medical Device Problem Code	Ambient Temperature Problem (2878)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed for the potential of serious injury as this was an emergent case.There was no reported death or serious injury to the patient.A backstock of dmso was used while the vial thawed.Storage instructions in the lava les ifu state to thaw the product at room temperature if it solidifies.Sirtex engineering has stated the design verification testing of the lava les was performed on lava vials that were subjected to environmental conditioning and distribution testing per astm f2825 and astm and met all performance and functional requirements.Dmso, the main constituent of the liquid embolic solution, has the physical property of freezing at about 18.55dc (65.4df).The product is shipped with 2-inches thick insulation plus 3 packs of 24 oz gel refrigerant (gel packs) per internal shipping procedures.A batch record review was performed and showed the device was manufactured to released specifications with passing quality test results and with no nonconformities or deviations.Sirtex medical affairs has stated this event appears to be related to shipping and handling rather than any issue with device performance or safety.There was no patient involvement or clinical impact, and the procedure was able to proceed as planned using available dmso while the delivered vial thawed.Review of the device history record for the affected lot did not identify any manufacturing issues, and this event does not change the overall safety profile of lava-18.
Event or Problem Description
Upon delivery, lava was needed right away.The dmso was frozen solid and needed to be thawed, therefore delaying the case.Extra dmso was available and used while the frozen dmso thawed.An improvement suggestion was offered to change the shipping contents to guarantee that no product is frozen upon arrival.

• 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: 24323106
• Report Number: 9710358-2026-00001
• Device Sequence Number: 9966512
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: (01)00850055697003(17)280503(10)10906
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 02/12/2026

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: 10906
• 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: 01/13/2026
• Initial Report FDA Received Date: 02/12/2026
• 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