MAUDE Adverse Event Report: BLACKSWAN VASCULAR, INC. LAVA-18, 6 ML; Embolization Agent, Vascular

Model Number	SLLES186
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A new review of this event was performed.A retrospective mdr has been filed out of an abundance of caution due to the potential for serious injury.The customer described lava 18 appeared in the ima after the endoleak was filled.The patient was admitted for observation for the possibility of small bowel ischemia.Ischemia is a potential complication described in the ifu as well as non-target vessel embolization.Follow up request for information on the patient status were sent.No additional patient information was received since hospital asked not to be contacted.Batch record review showed the device was manufactured to released specifications and had passing quality test results.
Event or Problem Description
During embolization procedure, lava 18 appeared in the ima after the endoleak was filled.Patient admitted for risk of small bowel ischemia.The patient was admitted for observation.

• Brand Name: LAVA-18, 6 ML
• Common Device Name: Embolization Agent, Vascular
• Manufacturer (Section D): BLACKSWAN VASCULAR, INC.; 709 sandoval way; hayward CA 94544
• Manufacturer Contact: melissa sanchez ; 709 sandoval way; hayward, CA 94544
• MDR Report Key: 22669055
• Report Number: 3005579300-2025-00004
• Device Sequence Number: 3825277
• Product Code: QVG
• UDI-Device Identifier: 00850055697027
• UDI-Public: (01)00850055697027(17)250310(10)10757
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2025
• Device Model Number: SLLES186
• Device Lot Number: 10757
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 07/30/2025
• 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