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

Model Number	SPVA-2010
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting for product return for analysis.
Event or Problem Description
A patient was implanted on tuesday, (b)(6) 2025 with an spva-2010 valve in ventriculo-atrial shunt (vas).The doctor was having difficulty adjusting the valve to position 2 (70 mmh2o).The patient presented a picture of hyperdrainage, and the doctor wished to adjust the valve to position 3 or 4.Despite numerous attempts (use of a single magnet, double magnet, with or without selector, repeated back-and-forth movements, etc.), it was impossible to change the valve position.After about an hour of unsuccessful attempts, the decision was taken to re-intervene surgically and replace the valve with another spva.The operation was performed without complications on saturday, (b)(6) 2025.
Additional Manufacturer Narrative
The root cause cannot be established.The product has been discarded and the serial number/lot number has not been saved.Under these circumstances, no analysis of the product or review of the batch file can be done.
Event or Problem Description
A patient was implanted on (b)(6) 2025 with an spva-2010 valve in ventriculo-atrial shunt (vas).The doctor was having difficulty adjusting the valve to position 2 (70 mmh2o).The patient presented a picture of hyperdrainage, and the doctor wished to adjust the valve to position 3 or 4.Despite numerous attempts (use of a single magnet, double magnet, with or without selector, repeated back-and-forth movements, etc.), it was impossible to change the valve position.After about an hour of unsuccessful attempts, the decision was taken to re-intervene surgically and replace the valve with another spva.The operation was performed without complications on (b)(6) 2025.

• Brand Name: POLARIS® SPVA KIT PREATTACHED / BO19-10
• Common Device Name: POLARIS® SPVA KIT PREATTACHED / BO19-10
• Manufacturer (Section D): SOPHYSA; 5 rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 4 rue guy moquet; FR 91400
• MDR Report Key: 22327022
• Report Number: 3001587388-2025-00055
• Device Sequence Number: 12834346
• Product Code: JXG
• UDI-Device Identifier: 03760124131314
• UDI-Public: 03760124131314
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: SPVA-2010
• Device Catalogue Number: SPVA-2010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 01/07/2026
• 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: Male