MAUDE Adverse Event Report: SOPHYSA POLARIS; POLARIS ADJUSTABLE PRESSURE VALVE

Model Number SPV

Device Problems Use of Incorrect Control/Treatment Settings (1126); Excess Flow or Over-Infusion (1311); Pressure Problem (3012)

Patient Problem Hydrocephalus (3272)

Event Date 05/13/2019

Event Type  malfunction  

Event Description

1st polaris valve implantation in (b)(6) 2019.Few days later, water spinal flow went far in flowing.Surgeon could not valve control setting pressure.Consequences for the patient : overdrainage after several attempts to adjust te pressure, the surgeon replaced the valve ((b)(6) 2019): explantation of the polaris valve and replacement by another one.After surgery, when confirmed by ct, symptoms improved and ventricular size was stable.

• Brand Name: POLARIS
• Type of Device: POLARIS ADJUSTABLE PRESSURE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer (Section G): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• Manufacturer Contact: philippe ; 5 rue guy moquet; orsay, 91400
• MDR Report Key: 8811582
• MDR Text Key: 152087754
• Report Number: 3001587388-2019-19317
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention