MAUDE Adverse Event Report: SOPHYSA POLARIS® ADJUSTABLE VALVE / 5 PRESS. 80-400; SPV400

Model Number	SPV400
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient is suffering from hydrocephalus and has been implanted by adjustable valve with ventriculoperitoneal shunt since 2016.On the (b)(6) 2024, the patient underwent a procedure to change the shunt due to headaches.There was no obstruction, however both of the valve and the intracerebral catheter were replaced with a polaris valve and intracerebral catheter from sophysa.The following day, there was no improvement in the patient's health state even after several valve adjustments.On the (b)(6) 2024, the patient returned to the operating room to replace the polaris valve due to the fact that the state of health is not improving.The valve is malfunctioning and obstructed at the extremity of it and the peritoneal catheter.The physician replaced the polaris valve with another adjustable valve.The patient's condition has improved.
Additional Manufacturer Narrative
After receiving the product, the laboratory carried out several analyses about the aspect control at receipt of the valve, the valve is in position 4, there is a part of catheter with the inlet connector.There is a presence of dried organic residue.About pressure test without decontamination the valve is not compliant with sophysa's specification, the mechanism is blocked in due to presence of dried organic residue.About the adjustement of the valve, the test is conform.In conclusion, the obstruction is the cause, the obstruction is a well-known phenonem, well documented in the accompanying documentation.
Event or Problem Description
The patient is suffering from hydrocephalus and has been implanted by adjustable valve with ventriculoperitoneal shunt since 2016.On the (b)(6) 2024, the patient underwent a procedure to change the shunt due to headaches.There was no obstruction, however both of the valve and the intracerebral catheter were replaced with a polaris valve and intracerebral catheter from sophysa.The following day, there was no improvement in the patient's health state even after several valve adjustements.On the (b)(6) 2024, the patient returned to the operating room to replace the polaris valve due to the fact that the state of health is not improving.The valve is malfunctioning and obstructed at the extremity of it and the peritoneal catheter.The physician replaced the polaris valve with another adjustable valve.The patient's condition has improved.

• Brand Name: POLARIS® ADJUSTABLE VALVE / 5 PRESS. 80-400
• Common Device Name: SPV400
• Manufacturer (Section D): SOPHYSA; rue sophie germain; besancon 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; re sophie germain; besancon, 25000 ; FR 25000
• Manufacturer Contact: marion prud'homme ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 18938758
• Report Number: 3001587388-2024-24076
• Device Sequence Number: 17903041
• Product Code: JXG
• UDI-Device Identifier: 03760124131291
• UDI-Public: (01)03760124131291(11)200228(17)250201(01)03760124131291(11)200228(17)250201
• 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 Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 02/01/2025
• Device Model Number: SPV400
• Device Catalogue Number: SPV400
• Device Lot Number: 306395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/21/2024
• 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: Other
• Patient Sex: Unknown