MAUDE Adverse Event Report: BLACKSWAN VASCULAR, INC. LAVA-18, 2 ML; LAVA LIQUID EMBOLIC SYSTEM

Model Number	SLLES182
Medical Device Problem Code	Insufficient Information (3190)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of our review of the lot history report (lhr) showed that the product met the production acceptance criteria per established manufacturing production instructions.The records also show that the sub-assembly production parts met the requirements and specifications per established manufacturing requirements, such as sterilization & verification by analytical laboratory and viscosity measurement.The product lot passed visual inspections of the les serum vials and passed the leak test.
Event or Problem Description
Doctor was administering dmso/lava to patient.Patient was on anesthesia.During the administration process, about 20 minutes after the lava product was administered, the patient experienced a drop in hr and became stemi.The ir md does not think that the dmso or the lava were contributory to the drop in hr and the drop seemed to coincide with the administration of some heparin to the patient.However, since lava was being used in proximity to the drop in hr, the doctor could not rule it out.

• Brand Name: LAVA-18, 2 ML
• Common Device Name: LAVA LIQUID EMBOLIC SYSTEM
• Manufacturer (Section D): BLACKSWAN VASCULAR, INC.; 709 sandoval way; hayward CA 94544
• Manufacturer Contact: vana poovala ; 709 sandoval way; hayward, CA 94544 ; 7817213862
• MDR Report Key: 19259542
• Report Number: 9710358-2024-00002
• Device Sequence Number: 6396989
• Product Code: QVG
• UDI-Device Identifier: 00850055697003
• UDI-Public: 00850055697003
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P220020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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: 09/25/2024
• Device Model Number: SLLES182
• Device Lot Number: 10553
• 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: 04/08/2024
• Initial Report FDA Received Date: 05/07/2024
• 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