MAUDE Adverse Event Report: KANEKA CORPORATION OSAKA PLANT LIPOSORBER LA-15 SYSTEM; APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN ADULT AND PEDIATRIC PATIENTS

Model Number	LA-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Restenosis (4576); Idiopathic Intracranial Hypertension (4588)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported adverse event involved a 15-year-old male patient (subject id: (b)(6)) who was admitted on (b)(6) 2025, for worsening headaches and concern for increased intracranial pressure.Imaging revealed stenosis of the distal right transverse sinus stent, and balloon angioplasty was performed on (b)(6) 2025.The liposorber la-15 system was last used on (b)(6) 2023.The device was not in use at the time of the event.The device was not available for evaluation as it had been discarded.A full device history record (dhr) review and site interviews were conducted.No device malfunction or defect was identified.The attending physician stated that the causal relationship between the device and the adverse event is unclear.Based on the completed investigation, the root cause of the event was not attributed to the device.The event is considered to be related to the patient's underlying condition and progression of the implanted stent.All applicable imdrf codes have been documented accordingly.Rationale for fda reporting: this event is being reported pursuant to 21 cfr part 803.50(a) as it involves a serious injury potentially associated with the use of a medical device.Although the device was not in use at the time of the event and no malfunction was identified, the event resulted in hospitalization and required medical intervention.The causal relationship between the device and the adverse event remains undetermined, but cannot be definitively ruled out.Furthermore, this case is part of a post-approval study (pas) required by the fda.As such, all serious adverse events occurring during the study period must be reported to ensure ongoing safety surveillance and regulatory compliance.This report is submitted as part of that obligation.
Event or Problem Description
Patient was admitted on (b)(6) 2025, with worsening headaches and suspected increased intracranial pressure.Imaging revealed stenosis of the distal right transverse sinus stent.Balloon angioplasty was performed on (b)(6) 2025.The device (liposorber la-15 system) was discarded at the facility and not returned, making evaluation impossible.According to the attending physician, the causal relationship between the device and the adverse event is currently unknown.This adverse event occurred approximately 22 months after the patient's last ldl apheresis treatment using the liposorber la-15 system.

• Brand Name: LIPOSORBER LA-15 SYSTEM
• Common Device Name: APHERESIS FOR FOCAL GLOMERULOSCLEROSIS IN ADULT AND PEDIATRIC PATIENTS
• Manufacturer (Section D): KANEKA CORPORATION OSAKA PLANT; 5-1-1, torikai-nishi,; settsu-shi, osaka 56600 72; JA 5660072
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1 torikai-nishi; settsu, osaka 56600 72; JA 5660072
• Manufacturer Contact: akihiro tahara ; minato-ku1-12-32; akasaka; tokyo 10760-28 ; JA 1076028
• MDR Report Key: 22379700
• Report Number: 3002808904-2025-00022
• Device Sequence Number: 8411199
• Product Code: PBN
• UDI-Device Identifier: 24993478010117
• UDI-Public: (01)24993478010117(17)260128(10)LAP1619
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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: 01/28/2026
• Device Model Number: LA-15
• Device Lot Number: LAP1619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 07/02/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Race: White