MAUDE Adverse Event Report: BLACKSWAN VASCULAR, INC. LAVA-34, 2 ML; EMBOLIZATION AGENT, VASCULAR

Model Number	SLLES342
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Pain (1994)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Two issues observed during the case: 1.Upon administration of dmso (0.5 ml, in accordance with dead space of catheter)), patient experienced significant pain, began thrashing uncontrollably on table, and blood pressure increased significantly.It took more than 60 minutes post procedure for anesthesia to once again stabilize patient and get back to normal.2.During the embolization of the gda, physician placed one coil distally after measuring the vessel at 3.5 mm.Initially, a 4mm coil was used which failed to deploy, so physician changed to a 3 mm coil.This coil deployed about 75% and the remaining tail was proximal towards the microcatheter tip where lava would be deployed to fill space.As physician began advancing lava at 0.3 ml/min rate, the lava became visible in gda and began to fill space between coil and catheter.Then lava was visualized in collateral vessels not adjacent to the gda (non-target areas).Physician stopped delivering lava at this point and placed 2 coils proximally to end case.Anesthesia was called to help get patient blood pressure and stabilize, which took 60+ minutes after procedure.
Additional Manufacturer Narrative
A lot history review of slles342 batch # 10858 (finished good) was performed, along with reviews of the following sub-assemblies: lava -34 batch # 10720, dmso batch # 10808, and dmso batch # 10837.It was concluded that all finished good and sub-assemblies were manufactured to released specifications, with passing quality test results and no deviations or nonconformances.Non-target embolization is a recognized as a potential adverse event and is listed in the ifu.Multiple emails were sent to the physician requesting a patient outcome follow-up for this case.No reply has been received.
Event or Problem Description
Two issues observed during the case: 1.Upon administration of dmso (0.5 ml, in accordance with dead space of catheter)), patient experienced significant pain, began thrashing uncontrollably on table, and blood pressure increased significantly.It took more than 60 minutes post procedure for anesthesia to once again stabilize patient and get back to normal.2.During the embolization of the gda, physician placed one coil distally after measuring the vessel at 3.5 mm.Initially, a 4mm coil was used which failed to deploy, so physician changed to a 3 mm coil.This coil deployed about 75% and the remaining tail was proximal towards the microcatheter tip where lava would be deployed to fill space.As physician began advancing lava at 0.3 ml/min rate, the lava became visible in gda and began to fill space between coil and catheter.Then lava was visualized in collateral vessels not adjacent to the gda (non-target areas).Physician stopped delivering lava at this point and placed 2 coils proximally to end case.Anesthesia was called to help get patient blood pressure and stabilize, which took 60+ minutes after procedure.

• Brand Name: LAVA-34, 2 ML
• Common Device Name: EMBOLIZATION AGENT, VASCULAR
• Manufacturer (Section D): BLACKSWAN VASCULAR, INC.; hayward CA
• Manufacturer Contact: melissa sanchez ; 709 sandoval way; hayward, CA 94544
• MDR Report Key: 21792644
• Report Number: 3005579300-2025-00001
• Device Sequence Number: 20810773
• Product Code: QVG
• UDI-Device Identifier: 00850055697010
• UDI-Public: (01)00850055697010(17)270817(10)10858
• 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
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Model Number: SLLES342
• Device Lot Number: 10858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown