MAUDE Adverse Event Report: SOPHYSA POLARIS ADJUSTABLE VALVE SPV

Model Number SPV

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

The valve was returned and a visual and functional tests have been performed.The returned valve was in position 1.Some marks are present on the valve body, certainly made when the valve was removed.The valve is very clean.The adjustment of the valve is conform to its specifications.Given the elements provided by the surgeon, dirt in the csf could have blocked the rotation movement.As a conclusion, the analysis did not find any anomaly in the valve which could explain the adjustment issue.However, a probable cause of the event is a biological debris that could have blocked the rotation movement.This cannot be confirmed as the returned valve was clean.

Event Description

The spv was implanted on (b)(6) 2016.On (b)(6): it was not possible to change the setting pressure on spv to high position from 110.When doctor tried to change the setting pressure to low position, it was able to change to 30.So doctor re-tried to change it to high position, it could not change.As doctor confirmed over drainage, the valve was replaced.After the valve was removed from the patient and cleaned, the pressure was able to change to 200.

• Brand Name: POLARIS ADJUSTABLE VALVE SPV
• Type of Device: POLARIS ADJUSTABLE VALVE SPV
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; rue sophie germain; besancon, 25000 ; FR 25000
• Manufacturer Contact: hanta ranaivoson ; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 11383690
• MDR Text Key: 264063364
• Report Number: 3001587388-2021-21084
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2020
• Device Model Number: SPV
• Device Catalogue Number: SPV
• Device Lot Number: C0317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR