MAUDE Adverse Event Report: SIRTEX MEDICAL, INC. LAVA-34, 6 ML; EMBOLIZATION AGENT, VASCULAR

Model Number	SLLES346
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event did not involve death or serious injury and it was stated the case was completed with a different device.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 and the procedural delay in transitioning to a different device.The 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.The batch record review found the device to be manufactured in accordance with the approved specifications.The radiopacity of the device is dependent on the the tantalum added to the product during manufacturing and tantalum amounts were found to be within specification.The investigation is on-going as the customer has stated they will return the device.Based on the information currently available, sirtex medical affairs has stated reduced visualization may theoretically impact embolic control and increase the risk of non-target embolization; however, this is a known procedural consideration mitigated through standard practice, including fluoroscopic monitoring and cessation of delivery if visualization is inadequate.Manufacturing review confirmed the device met all specifications, and no device deficiency has been identified.Overall, this represents a device performance concern without patient harm, with low to remote risk of injury.
Event or Problem Description
The physician was performing an evar type 2 endoleak procedure and stated the lava 34 did not have its usual opacity and was very hard to see.The case was completed with a different device.

• Brand Name: LAVA-34, 6 ML
• Common Device Name: EMBOLIZATION AGENT, VASCULAR
• Manufacturer (Section D): SIRTEX MEDICAL, INC.; 300 unicorn park dr, 2nd floor; fl. 2; woburn MA 01801
• Manufacturer Contact: melissa sanchez ; 300 unicorn park drive; fl. 2; woburn, MA 01801
• MDR Report Key: 24715188
• Report Number: 9710358-2026-00010
• Device Sequence Number: 5740329
• Product Code: QVG
• UDI-Device Identifier: 00850055697034
• UDI-Public: (01)00850055697034(17)280426(10)10892
• 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,Followup
• Report Date (Section B): 06/11/2026

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: SLLES346
• Device Lot Number: 10892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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