MAUDE Adverse Event Report: SOPHYSA POLARIS® SPV ADJUSTABLE VALVE

Model Number	SPV
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An incident occured on a spv valve, the product has been found obstructed.The valve has been explanted and replaced by another spv valve on (b)(6) 2024.The patient is a 7 years old child that presented a hyperproteinemia.
Additional Manufacturer Narrative
Our quality department conducted various analyses on the returned device: visual inspection : the valve shows a few residues of organic origin that can be seen in the valve chamber, around the ball of the spring-ball-cone system used to control operating pressure differential.Pressure testing before decontamination : the valve is back in position 3 at 117, which is compliant.All pressures are compliant except for the high pressure, which is at 224 instead of 215 max (p5).Comparison of the measured pressure values with the data recorded at the end of production shows a slight drift towards the upper limits of the tolerances for all positions, with the maximum acceptable resistance exceeded for position p5.Programing control before decontamination: conform.The batch file has been reviewed and the polrais valve complies with the expected specifications when released from production.In conclusion , all the values are higher than the values recorded at the end of production, coinciding with an obstruction at the median position.Residuals at the device ball also point in this direction.The most probable case is that irreversible increase occured in the valve's intrinsic resistance when it is set in the high position, which is the consequence of an agglomerate residuals pressing onto the valve spring.The obstruction is a well-known phenomenon documented in the accompanying documents and risk analysis.This report is being resubmitted because the previous report sent on 04/25/2025 (increment 00023) was not accepted.
Event or Problem Description
An incident occured on a spv valve, the product has been found obstructed.The valve has been explanted and replaced by another spv valve on (b)(6) 2024.The patient is a 7 years old child that presented a hyperproteinemia.

• Brand Name: POLARIS® SPV ADJUSTABLE VALVE
• Common Device Name: POLARIS® SPV ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; 5 rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 21489350
• Report Number: 3001587388-2025-25065
• Device Sequence Number: 15557079
• Product Code: JXG
• UDI-Device Identifier: 03760124131253
• UDI-Public: 03760124131253
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: SPV
• Device Catalogue Number: SPV
• Device Lot Number: L002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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: Other; Required Intervention
• Patient Age: 7 YR
• Patient Sex: Unknown