MAUDE Adverse Event Report: SOPHYSA POLARIS® ADJUSTABLE VALVE; POLARIS® SPV ADJUSTABLE VALVE

Model Number	SPV
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The valve spv was implanted in (b)(6) 2023 and adjusted at 150 mmh2o.On (b)(6) 2025, the patient was admitted to emergency with headaches.The valve was adjusted at 200 mmh2o and the doctor readjusted the valve to 150 mmh2o.On (b)(6) 2025, the patient returned to hospital as his state of health had not improved.The valve was explanted and replaced with the spv 300 and adjusted to 150 mmh2o.Following valve replacement, the patient's health condition improved.
Additional Manufacturer Narrative
Our quality department conducted various analyses on the returned device : visual inspection : the valve was returned quite clean, immersed in sterile water.The valve was set to position p5.Organic residues were observed inside the valve chamber and on the spring.Pressure testing : the valve was not compliant; an increase was observed for all pressure values between the values after production release and the values after return.However, all pressure values were compliant (including in tolerance range) except for the pressure p5, which was at 245 mmh2o, exceeding the maximum of 215 mmh2o.Programming testing : the valve was compliant.The batch file has been reviewed and the valve complies with the expected specifications when release from production.All pressure values increased compared to when the valve was released from production, and only one pressure position (p5) was not compliant.However, this non-conformity does not explain the deprogramming issue observed (the valve shifting from 150 to 200 mmh2o).There are no x-ray images to confirm the pressure reading, and the programming test is compliant.Regarding the lack of improvement in the patient's health after readjusting to 150 mmh2o, according to the visual inspection one of the hypotheses may be the passage of organic residues through the ball-in-cone mechanism, which could cause a decalibration of the spring and an increase in all pressure values.In conclusion, the root cause cannot be identified because the incident which is the deprogramming of the valve, cannot be explained after product analysis.Follow up : this report is being resubmitted because the previous report sent on 04/25/2025 (increment 00024) was not accepted.
Event or Problem Description
The valve spv was implanted in (b)(6) 2023 and adjusted at 150 mmh2o.On (b)(6) 2025, the patient was admitted to emergency with headaches.The valve was adjusted at 200 mmh2o and the doctor readjusted the valve to 150 mmh2o.On (b)(6) 2025, the patient returned to hospital as his state of health had not improved.The valve was explanted and replaced with the spv 300 and adjusted to 150 mmh2o.Following valve replacement, the patient's health condition improved.

• Brand Name: POLARIS® ADJUSTABLE VALVE
• Common Device Name: POLARIS® SPV ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 21478993
• Report Number: 3001587388-2025-25066
• Device Sequence Number: 8436371
• Product Code: JXG
• UDI-Device Identifier: 03760124131253
• UDI-Public: (01)03760124131253(11)220311(17)270301
• 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 Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: SPV
• Device Catalogue Number: SPV
• 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: 02/27/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• 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: 50 YR
• Patient Sex: Male