MAUDE Adverse Event Report: SOPHYSA POLARIS SPV ADJUSTABLE VALVE /BURR HOLE RESERVOIR

Model Number	SPVB
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient has been implanted with the polaris valve.Due to suspected shaft dysfunction, it was replaced from spvb to spva valve on (b)(6) 2024.The ventricular catheter was also replaced.The reason is the difficulty in changing the pressure of the valve before the surgery and the visible deposits inside the removed valve.
Event or Problem Description
The patient has been implanted with the polaris valve.Due to suspected shaft dysfunction, it was replaced from spvb to spva valve on (b)(6) 2024.The ventricular catheter was also replaced.The reason is the difficulty in changing the pressure of the valve before the surgery and the visible deposits inside the removed valve.
Additional Manufacturer Narrative
The device is still in investigation by the manufacturer.
Additional Manufacturer Narrative
Our quality department conducted various analyses on the returned device: visual inspection: the reservoir shows stitch marks from sutures, as well as the presence of organic residue in the reservoir and valve ball.Additionally, the reservoir connector appears to be twisted.Pressure testing before decontamination: compliant.Programming control before decontamination: not compliant.The batch file has been reviewed, and the valve meets the expected specifications at the time of release from production.In conclusion, the difficulties encountered by practitioners in adjusting the device are attributed to the organic residues present inside the device.This phenomenon is well-known and has been documented in the risk analysis.
Event or Problem Description
The patient has been implanted with the polaris valve.Due to suspected shaft dysfunction, it was replaced from spvb to spva valve on (b)(6) 2024.The ventricular catheter was also replaced.The reason is the difficulty in changing the pressure of the valve before the surgery and the visible deposits inside the removed valve.

• Brand Name: POLARIS SPV ADJUSTABLE VALVE /BURR HOLE RESERVOIR
• Common Device Name: POLARIS SPV ADJUSTABLE VALVE /BURR HOLE RESERVOIR
• Manufacturer (Section D): SOPHYSA; 5 rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; 5 rue sophie germain; technopoletemis; besancon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 20479074
• Report Number: 3001587388-2024-24343
• Device Sequence Number: 8360135
• Product Code: JXG
• UDI-Device Identifier: 03760124131321
• UDI-Public: 01037601241313211721050110223825
• 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: 2017
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 01/17/2025

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 Expiration Date: 04/26/2021
• Device Model Number: SPVB
• Device Catalogue Number: SPVB
• Device Lot Number: D0279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 10/03/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 12/19/2024; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Male