MAUDE Adverse Event Report: SOPHYSA POLARIS® SPV-140 ADJUSTABLE VALVE / ANTECHAMBER

Model Number	SPVA-140
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Difficult adjustment after implantation using the adjustment kit.
Additional Manufacturer Narrative
This follow-up report is related to the previous initial report with the mfr report number 00030.The purpose of this report is to correct the g3 answer "date received by manufacturer" by 04/22/2025.Indeed, in the initial report the date was 05/01/2025 which was incorrect.This report is being resubmitted because the previous report (follow up 1) sent on 05/15/2025 (increment 00032) was not accepted.
Event or Problem Description
Difficult adjustment after implantation using the adjustment kit.
Event or Problem Description
Difficult adjustment after implantation using the adjustment kit.
Additional Manufacturer Narrative
Our quality department conducted various analyses on the returned device : - visual inspection : the valve was returned quite clean.The valve was set to position p1.The valve is connected to a reservoir resembling an omay, not manufactured by us, as well as a piece of orange-colored catheter, also not identified as one of our products.- pressure testing : the valve was not compliant, all pressure values were compliant (including in tolerance range) except for the pressure p5, which was at 161 mmh2o, exceeding the maximum of 155 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 malfunction.Indeed, a programming test was performed using a leather model and a pak2, and no issues were encountered.Based on our experience on the filed, the most plausible explanation is that, during the reprogramming attempt, the magnet was not properly positioned.In the case of a valve connected to a reservoir, the magnet must apply sufficient pressure to "compress" the reservoir and bring the internal components of the valve closer together to enable unlocking.Finally, if the magnet is not correctly centered over the valve, the internal shuttles will not open, making it impossible to change the valve setting.However, we were unable to confirm this explanation based on the information available.In conclusion, the valve complies with the programming test.The root cause is not identified.This report is being resubmitted because the previous report sent on 06/25/25 (increment 00030) was not accepted.

• Brand Name: POLARIS® SPV-140 ADJUSTABLE VALVE / ANTECHAMBER
• Common Device Name: POLARIS® SPV-140 ADJUSTABLE VALVE / ANTECHAMBER
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22018686
• Report Number: 3001587388-2025-00030
• Device Sequence Number: 13144244
• Product Code: JXG
• UDI-Device Identifier: 03760124131604
• UDI-Public: (01)03760124131604(11)241127(17)290901
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K141227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

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: SPVA-140
• Device Catalogue Number: SPVA-140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 04/22/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 04/10/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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
• Patient Sex: Unknown