MAUDE Adverse Event Report: SOPHYSA POLARIS® SPV ADJUSTABLE VALVE

Model Number	SPV
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending for product return to the manufacturer.
Event or Problem Description
On may 22, revision surgery was performed on a patient with an spv implant, and the spv was placed in the same location.On the following day, may 23, the pressure was attempted to be changed, but this was not possible.Despite prolonged attempts under fluoroscopy, the micro magnet did not move, so surgery was performed in the afternoon on may 23rd, and another spv was implanted.The doctor requested a replacement.The micro magnet from the removed valve could be moved with a magnet, so there was no reoccurrence.
Event or Problem Description
On (b)(6), revision surgery was performed on a patient with an spv implant, and the spv was placed in the same location.On the following day, (b)(6), the pressure was attempted to be changed, but this was not possible.Despite prolonged attempts under fluoroscopy, the micro magnet did not move, so surgery was performed in the afternoon on (b)(6), and another spv was implanted.The doctor requested a replacement.The micro magnet from the removed valve could be moved with a magnet, so there was no reoccurrence.
Additional Manufacturer Narrative
Our quality department conducted various analyses on the returned device : visual inspection : the valve was returned quite clean, immersed in water.The valve was set to position p3.Programming testing : no issues were observed: the magnet unlocking functioned correctly.However, starting from the tenth cycle, we noticed abnormal behavior: the valve begins to rotate partially, with the magnets getting stuck between two positions.As a result, the programming becomes faulty.The reported issues have been confirmed.The valve programming does not meet our quality requirements.Based on our experience, it is possible that a physiological particle may have blocked the valve mechanism, preventing the magnets from unlocking and thus making it impossible to adjust the valve to another position.This could explain the programming malfunctions and the abnormal magnet movements observed.Repeated attempts to adjust the valve may have progressively led to a malfunction, which would explain the incorrect pressure values measured.

• Brand Name: POLARIS® SPV ADJUSTABLE VALVE
• Common Device Name: POLARIS® SPV ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; rue sophie germain; besancon, 25000 ; FR 25000
• 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: 22218245
• Report Number: 3001587388-2025-00054
• Device Sequence Number: 8132363
• Product Code: JXG
• UDI-Device Identifier: 03760124131253
• UDI-Public: 3760124131253
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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
• Operator of Device: Health Professional
• Device Model Number: SPV
• Device Catalogue Number: SPV
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: 76 YR
• Patient Sex: Female