MAUDE Adverse Event Report: SOPHYSA POLARIS ADJUSTABLE VALVE, 30-200 WITH ANTECHAMBER AND SIPHONX

Model Number	SPVA-SX
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient who had a shunt valve implanted at (b)(6) hospital on (b)(6) 2023 was later transferred to (b)(6) hospital.During pumping, there was discomfort with the valve.Suspecting a blockage, the valve was replaced with a product from another manufacturer.
Additional Manufacturer Narrative
Initial: pending device investigation.

• Brand Name: POLARIS ADJUSTABLE VALVE, 30-200 WITH ANTECHAMBER AND SIPHONX
• Common Device Name: POLARIS ADJUSTABLE VALVE, 30-200 WITH ANTECHAMBER AND SIPHONX
• 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: 25267745
• Report Number: 3001587388-2026-00040
• Device Sequence Number: 21133499
• Product Code: JXG
• UDI-Device Identifier: 03760124131710
• UDI-Public: (01)03760124131710(11)190927(17)240901
• 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: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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 Expiration Date: 09/01/2024
• Device Model Number: SPVA-SX
• Device Catalogue Number: SPVA-SX
• Device Lot Number: 295162/ 26880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/25/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2019
• 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 Age: 32 YR
• Patient Sex: Male