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

Model Number	SPVB-2010
Medical Device Problem Codes	Obstruction of Flow (2423); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hydrocephalus (3272); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The valve was replaced during a surgery on a patient for a reason that, apparently, was not related to the valve.According to the information shared by the physician, the doctor prefers to replace the valve to ensure the patient receives the best value and care.The doctor also confirmed that the valve appeared to be functioning normally.Since we do not have information regarding the reason for the procedure, we have decided to report this case.
Event or Problem Description
We have received additional information since the initial report concerning the incident description.The valve was implanted following a severe ventricular bleed that required extensive external ventricular drainage.Shortly after placement of the valve, patient symptoms pointed to hydrocephalus.According to the patient's clinical history, the doctor would not be surprised if this patient experienced valve failure, such as an obstruction, due to clotting.The doctor decided to explant the valve and flushed it.He did not feel much resistance with flushing, and in fact it flushed without resistance.He recognized that he may have "power flushed" the valve and cleared the clot without knowing.That is why the doctor explained to us that the explantation was not related to the device.According to the information shared by the physician, the doctor prefers to replace the valve to ensure the patient receives the best value and care and he also confirmed that the valve appeared to be functioning normally.
Additional Manufacturer Narrative
Our quality department conducted various analyses on the returned device: visual inspection: the valve was returned and set to position p3.The valve is connected to a reservoir.The reservoir showed needle puncture marks, and organic residues were identified inside the valve body.Pressure testing: the valve was compliant.All pressure values were checked, and the pressure at position p3 (return pressure on the valve) is within the acceptable range.Programming testing: the valve was compliant.The batch file has been reviewed and the valve complies with the expected specifications when release from production.Based on the description from the physician, the symptoms of hydroceaphalus may be related to a partial obstruction due to clotting and the flushing of the physician after explantation may clean the clot inside the valve.In conclusion, the valve complies with our specifications, there is no problem found on the product.The symptoms of hydrocephalus, which may indicate a potential partial obstruction, could be related to the patient's clinical history and are therefore not considered to be related to the device.

• Brand Name: POLARIS® SPVB KIT PREATTACHED / BO19- 10
• Common Device Name: POLARIS® SPVB KIT PREATTACHED / BO19-10
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; technopole temis; besançon, 25000 ; FR 25000
• Manufacturer Contact: julie lopez ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 22194549
• Report Number: 3001587388-2025-00051
• Device Sequence Number: 9189103
• Product Code: JXG
• UDI-Device Identifier: 03760124131338
• UDI-Public: (01)03760124131338(11)230223(17)271201
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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 Model Number: SPVB-2010
• Device Catalogue Number: SPVB-2010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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