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

Model Number	SLLES186
Medical Device Problem Codes	Material Puncture/Hole (1504); Pressure Problem (3012); Poor Visibility (4072)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being filed as serious injury to the patient occurred during a procedure where one of the devices used was lava-18.The review of the batch record and associated component lots found that the lava-18 device did not display any abnormal findings for the manufacturing process.The lava ifu states to use microcatheters that are dmso compatible.During the investigation, it was learned that the terumo progreat lambda catheter (175cm) microcatheter ifu states organic solvents may cause damage to the mircocatheter.Additionally, t2 endoleak is not listed on the lava ifu.Sirtex has followed up with the facility and has learned the patient is doing well and that no surgical intervention was needed.Sirtex medical affairs has reviewed the case and has stated the reported event describes increased injection resistance with unintended lava delivery, in the setting of use for a t2 endoleak and with a microcatheter that may not be dmso-compatible, both outside ifu recommendations.This represents a serious adverse event, with findings most consistent with a catheter-related issue (e.G., incompatibility or rupture).The ifu specifically warns to use dmso-compatible microcatheters and to stop injection if resistance is encountered, as excessive pressure may result in catheter damage and unintended embolization.The relationship to lava is assessed as possibly related in the context of use, but more directly attributable to off-label use conditions and device-user interface factors.The event is expected, given known risks outlined in the ifu.
Event or Problem Description
A physician experienced pressure in the syringe while delivering lava-18 for a t2 endoleak using a terumo progreat lambda catheter (175cm).The physician stated the pressure was not allowing them to deliver the lava but continued with the procedure when the pressure resolved.Upon viewing the angio screen, the lava was seen lower/inferior to where the catheter tip was located near the endoleak.The decision was made to stop administration, and to remove the catheter.A hole on the catheter was discovered.It was unknown if the hole was present before the procedure.The physician performed a percutaneous stick using lava-18 which successfully treated the endoleak.It was stated that there was a potential for ischemia in the bowel and the patient was being monitored.

• Brand Name: LAVA-18, 6 ML
• Common Device Name: Embolization Agent, Vascular
• Manufacturer (Section D): SIRTEX MEDICAL, INC.; 300 unicorn park dr.; 2nd fl.; woburn MA 01801
• Manufacturer Contact: melissa sanchez ; 300 unicorn park dr.; 2nd fl.; woburn, MA 01801
• MDR Report Key: 25073322
• Report Number: 9710358-2026-00013
• Device Sequence Number: 10418247
• Product Code: QVG
• UDI-Device Identifier: 00850055697027
• UDI-Public: (01)00850055697027(17)270623(10)10946
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: SLLES186
• Device Lot Number: 10946
• Was Device Available for Evaluation?: No
• 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: 04/06/2026
• Initial Report FDA Received Date: 05/04/2026
• 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