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

Model Number	SLLES182
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No death or serious injury were reported due to the malfunction as the device was not used on a patient.This mdr has been filed out of an abundance of caution, due to the potential for death or serious injury if the loss of visualization of the lava were to occur during a procedure causing non-target embolism.A batch record review was performed and no deviations or issues associated with the lot were found.Additionally, the recorded mass-per-vial data were reviewed, and all vials were documented as being within the established specifications.No discrepancies were identified that would indicate a manufacturing deficiency or concern with tantalum content.Sirtex has made multiple attempts to obtain the device for further investigation, but the device has not been returned.Should the device be received by sirtex, a follow-up report will be provided after the investigation.
Event or Problem Description
The physician notified sirtex medical that one of the lava vials they had in stock seemed very diluted and appeared to have little to no tantalum in it.The device was not used on the patient but the physician mixed the device on the vortex mixer for 20 minutes and noted the vial appeared "watered down" as they prepared to aspirate.Additionally, the physician performed the mixing using the mixing kit.The physician placed the device under fluoroscopy and noted that it was not radiopaque.

• Brand Name: LAVA-18, 2 ML
• Common Device Name: Embolization Agent, Vascular
• Manufacturer (Section D): BLACKSWAN VASCULAR, INC.; 300 unicorn park dr; 2nd floor; woburn MA 01801
• Manufacturer Contact: melissa sanchez ; 300 unicorn park drive; 2nd floor; woburn, MA 01801
• MDR Report Key: 23757203
• Report Number: 9710358-2025-00017
• Device Sequence Number: 21352212
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: (01)00850055697003(11)250322(17)280322(10)10873
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/09/2025

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: 10873
• 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: 11/18/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2025
• 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