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

Model Number	SPVA-2010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is still in investigation.
Event or Problem Description
A malfunction has been observed on a spva-2010 device by the hospital practitioners.It concerns a ventricular shunt valve, implanted on (b)(6) 2021, which presented no connection problems at the implantation time, but then showed to be dysfunctional on use.The valve has been replaced.
Event or Problem Description
A malfunction has been observed on a spva-2010 device by the hospital practitioners.It concerns a ventricular shunt valve, implanted on (b)(6) 2021, which presented no connection problems at the implantation time, but then showed to be dysfunctional on use.The valve has been replaced.
Additional Manufacturer Narrative
Our quality department conducted various analyses on the returned device: visual inspection: presence of organic residues in the valve body.Presence of marks on the valve body related to the explantation of the device.Absence of the reservoir with the returned device.Pressure testing before decontamination : the pressure values did not conform.The measured pressure in the state of return (p1) did conform with its specification.However, for pressure values p3, p4, and p5, they did not conform with the specification.P3 is measured at 134 mmh2o with a maximum of 125 mmh2o, p4 is measured at 181 mmh2o with a maximum of 165 mmh2o, and p5 is measured at 284 mmh2o with a maximum of 215 mmh2o.Programming control : the valve did conform pressure testing after cleaning with alcohol : the organic residues have been removed from the valve body.The pressure values (p3, p4, p5) are still non-compliant but closer to maximum tolerances.P3 is measured at 126 mmh2o with a maximum of 125 mmh2o, p4 is measured at 175 mmh2o with a maximum of 165 mmh2o, and p5 is measured at 252 mmh2o with a maximum of 215 mmh2o.The batch file has been reviewed and the valve complies with the expected specifications when release from production.In conclusion, the valve assembly did not comply with its specifications.The valve shows a variation in pressure values on some of the other positions, reduced by valve cleaning.This seems to demonstrate that the presence of residues is indeed the cause of this variation.Therefore, the root cause of the device explantation is the passage of these organic residues in the valve body which implies a disruption in the proper functioning of the valve even though the valve pressure in the return state is within specifications.The report is the follow up 1 of the case 3001587388-2025-25055.This report including an analysis of the device.Follow up : this report is being resubmitted because the previous report sent on 04/04/2025 (increment 00006) was not accepted.

• 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; besançon, 25000 ; FR 25000
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 21408543
• Report Number: 3001587388-2025-25055
• Device Sequence Number: 9576046
• Product Code: JXG
• UDI-Device Identifier: 03760124131314
• UDI-Public: 0103760124131314111902161724020110269765
• 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: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• 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): 04/09/2026

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 Expiration Date: 02/01/2024
• Device Model Number: SPVA-2010
• Device Catalogue Number: SPVA-2010
• Device Lot Number: 269755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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: Unknown