MAUDE Adverse Event Report: Sirtex Medical, Inc. LAVA-34, 6mL; 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	07/09/2026
Type of Reportable Event	Malfunction

• Brand Name: LAVA-34, 6mL
• Common Device Name: Embolization Agent, Vascular
• Manufacturer (Section D): Sirtex Medical, Inc.; 300 unicorn park drive; fl. 2; woburn MA 01801
• Manufacturer Contact: melissa sanchez ; 300 unicorn park drive; fl. 2; woburn, MA 01801
• MDR Report Key: 50178262
• Report Number: 9710358-2026-00021
• Device Sequence Number: 9880309
• Product Code: QVG
• UDI-Device Identifier: 00850055697034
• UDI-Public: (01)00850055697034(17)281209(10)9000287
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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
• Device Model Number: SLLES346
• Device Lot Number: 9000287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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