MAUDE Adverse Event Report: SOPHYSA SA POLARIS VALVE; POLARIS ADJUSTABEL VALVE

Model Number SPVA

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423)

Patient Problem Hydrocephalus (3272)

Event Date 05/15/2018

Event Type  malfunction  

Event Description

The user indicates us the patient has been implanted of an and just able valve in the skull region.The valve has been explanted because the user suspected the occlusion of the valve.

Manufacturer Narrative

The device was returned to our manufacturing facility for analysis following our quality control procedure.Visual examination : the valve and the reservoir are full of brown liquid with a lot of deposits inside.Functional controls : the ability of the valve to perform was tested.In the state of return, the valve is possible to flush very easily with air ( making the brown liquid to come out).It confirms that there is no obstruction.The ability to turn the rotor was tested upon return and after cleaning.The rotation is possible both before and after cleaning.The valve is compliant.It is not possible to measure the pressures because there are still deposits inside the valve even after cleaning.The valve is 100% controlled ( pressure/ flow characteristics, visual controls etc) during the manufacturing.A review of the fabrication record showed no anomalies.In conclusion the returned device meets its specification.The issue faced by the user could not be reproduced under laboratory conditions.

Event Description

The user indicates us the patient has been implanted of an adjustable valve in the skull region.The valve has been explanted because the user supected the occlusion of the valve.

• Brand Name: POLARIS VALVE
• Type of Device: POLARIS ADJUSTABEL VALVE
• Manufacturer (Section D): SOPHYSA SA; 5 rue guy moquet; orsay 91400 ; FR 91400
• MDR Report Key: 7624255
• MDR Text Key: 111845475
• Report Number: 3001587388-2018-18243
• 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: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: SPVA
• Device Catalogue Number: SPVA
• Device Lot Number: E0348
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR