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

Model Number	SPV-2010
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The infection was traced to the surgery procedure; the shunt has been removed by precaution.The root cause of the infection is linked to the surgery procedure and the shunt was not implicated.All these information have been confirmed by the hospital and the incident was considered as predictible.The incident has not been reported by the hospital, since sophysa was following the procedure for clinical investigation directly at the healthcare facility.The incident was therefore reported by the sophysa team out there.
Event or Problem Description
A 5-month old baby had an infection following the surgery and the decision to explant a polaris valve has been taken by the neurosurgeon, a temporary external derivation was placed while awaiting for the implantation of a new sophysa valve : polaris 24 (spv24).This implantation was performed during clinical investigation and the spv24 valve is not yet marketed by sophysa.The infection was traced to surgery procedure, the shunt has been removed by precaution.All these information have been confirmed by the hospital and the incident was considered as predictible.

• Brand Name: POLARIS® SPV KIT PREATTACHED / BO19-10
• Common Device Name: POLARIS® SPV KIT PREATTACHED / BO19-10
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• 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: 24290899
• Report Number: 3001587388-2026-00009
• Device Sequence Number: 9332972
• Product Code: JXG
• UDI-Device Identifier: 03760124131277
• UDI-Public: 03760124131277
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

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-2010
• Device Catalogue Number: SPV-2010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 5 MO
• Patient Sex: Unknown