MAUDE Adverse Event Report: SOPHYSA POLARIS SPVA KIT PREATTACHED /BO19-10

Model Number	SPVA-2010
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with a polaris valve on (b)(6) 2026.During a follow-up examination conducted on (b)(6) 2026, the physician observed that the valve was clogged and was not functioning properly.As a result of the device malfunction, the valve was surgically explanted and replaced with another valve.
Event or Problem Description
The patient was implanted with a polaris valve on 04 june 2026.During a follow-up examination conducted on (b)(6) 2026, the physician observed that the valve was clogged and was not functioning properly.As a result of the device malfunction, the valve was surgically explanted and replaced with another valve.
Additional Manufacturer Narrative
In conclusion, this malfunction is caused by a rare dimensional defect.Since then, this defect has been addressed throught corrective actions implemented within our manufacturing process.Those corrective actions include a 100% individual inspection of the the inlet connector rather than statistical sampling control to prevent recurency.

• Brand Name: POLARIS SPVA KIT PREATTACHED /BO19-10
• Common Device Name: POLARIS SPVA KIT PREATTACHED /BO19-10
• 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: 25870291
• Report Number: 3001587388-2026-00066
• Device Sequence Number: 16116088
• Product Code: JXG
• UDI-Device Identifier: 03760124131314
• UDI-Public: (01)03760124131314(11)251202(17)301001
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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: SPVA-2010
• Device Catalogue Number: SPVA-2010
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2026
• 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: 07/07/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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: 62 YR
• Patient Sex: Female