MAUDE Adverse Event Report: Sophysa POLARIS ADJUSTABLE VALVE

Model Number	SPV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Speech Disorder (4415)
Date of Event	07/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon suspected a possible valve malfunction.The valve was explanted several days after the surgery.
Additional Manufacturer Narrative
The reported event involved clinical deterioration following implantation of a sophysa spv valve, leading to device replacement.During the complaint investigation, it was determined that the returned device was a spv valve and not a spv-140 valve as initially reported.Device identification was confirmed through analysis of the returned product.Device investigation revealed obstruction of the valve mechanism and elevated operating pressures at all programmable settings, consistent with an under-drainage condition.Blood-stained fluid and physiological residues were observed inside the valve.Manufacturing history review confirmed that the device met all release specifications, and dimensional inspection did not identify any manufacturing-related deficiency or design anomaly.Based on the available evidence, the most probable root cause of the malfunction is obstruction of the valve mechanism by physiological material (blood products and/or tissue debris) accumulated during clinical use.This obstruction likely interfered with normal valve operation, resulting in increased operating pressures and reduced cerebrospinal fluid drainage.No evidence of manufacturing defect was identified.The reported event is therefore attributed to in vivo obstruction of the valve by physiological material.

• Brand Name: POLARIS ADJUSTABLE VALVE
• Common Device Name: POLARIS ADJUSTABLE VALVE
• Manufacturer (Section D): Sophysa; 5 rue guy moquet; orsay 91400 ; FR 91400
• Manufacturer (Section G): Sophysa; rue sophie germain; technopole temis; besancon 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay 91400 ; FR 91400
• MDR Report Key: 25905696
• Report Number: 3001587388-2026-00069
• Device Sequence Number: 20951434
• Product Code: JXG
• UDI-Device Identifier: 03760124131253
• UDI-Public: (01)03760124131253(11)250923(17)300601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SPV
• Device Catalogue Number: SPV
• 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: 07/17/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• 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: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female