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

Model Number SPV

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problem Hydrocephalus (3272)

Event Date 11/22/2018

Event Type  malfunction  

Event Description

A (b)(6) year-old female patient was implanted with a ventriculo-peritoneal derivation using a polaris valve in 2016.The valve was adjusted on its second operating pressure.She was followed-up on a very regular basis from the initial surgery to the first occurrence of the issue : on (b)(6) 2018 she presented with enlarged ventricles on a ct scan.The valve was found to be set on the highest operating pressure (which was confirmed by the adjustment tool and x-ray), explaining the typical hydrocephalus imaging seen on the ct.The valve was adjusted with the adjustment kit on its initial setting level but found to be too low on the confirmation x-ray.It was adjusted again, and the patient showed clinical improvement.She presented unwell 10 days later, adjustment kit and x-ray underlined that the valve was adjusted on its highest pressure setting.The valve was explanted and replaced.

Manufacturer Narrative

The device was returned to our manufacturing facility for quality analysis.Visual examination: the returned valve is clean and shows no particles or deposits that could have explained a possible pressure adjustment failure.The shuttles contained in the inner mechanism of the device appears to be unlock in the state of return.Functional controls: the ability of the valve to perform as intended was tested.Flushing air and alcohol through the inner mechanism remains possible and the mechanism is not stuck.Pressure adjustment remains possible in the state of return and after cleaning of the device.The shuttles of the rotor do not lock as they should after the adjustment operation is performed.The rotor position can easily be changed when the magnet of the adjustment kit is brought closer to the magnetic field of the valve.The adjustment issue faced by the user is confirmed by the quality analysis performed on the valve.Additional investigations are currently being performed on the valve in order to determine the root cause of the incident.Further information will be provided following these new analyses.

Event Description

A six-year-old female patient was implanted with a ventriculo-peritoneal derivation using a polaris valve in 2016.The valve was adjusted on its second operating pressure.She was followed-up on a very regular basis from the initial surgery to the first occurrence of the issue : on (b)(6) 2018 she presented with enlarged ventricles on a ct scan.The valve was found to be set on the highest operating pressure (which was confirmed by the adjustment tool and x-ray), explaining the typical hydrocephalus imaging seen on the ct.The valve was adjusted with the adjustment kit on its initial setting level but found to be too low on the confirmation x-ray.It was adjusted again, and the patient showed clinical improvement.She presented unwell 10 days later, adjustment kit and x-ray underlined that the valve was adjusted on its highest pressure setting.The valve was explanted and replaced.

• Brand Name: POLARIS
• Type of Device: POLARIS ADJUSTABLE PRESSURE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 8179426
• MDR Text Key: 131146998
• Report Number: 3001587388-2018-18558
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K031097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

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
• Device Operator: Health Professional
• Device Model Number: SPV
• Device Catalogue Number: SPV
• Device Lot Number: DO367
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 11/23/2018
• Supplement Dates FDA Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR