MAUDE Adverse Event Report: SOPHYSA POLARIS; POLARIS ADJUSTABLE VALVE

Model Number SPVA-2010

Device Problems Device Issue (2379); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hydrocephalus (3272)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

Sophysa has requested the user to send the device back to our facility for further analysis.Up until the day of this report (09/15/2016) , we are still waiting for the return of the device.

Event Description

A patient suffered from a dilatation of the ventricular system after implantation of the polaris valve.No alteration of the distal catheter to the valve system and intracranial catheter was observed during the surgical act, however without operating the system prior to the implantation.

Manufacturer Narrative

The shape and mechanism of the spring inside the valve do not show any particular defect.After analyses of the valve, we could not find any possible explanation to this low pressure.The only clear non-conformity of this evaluation is the low pressure of the highest position, but this cannot explain the difficulties encountered by the user, as the valve was adjusted on the first and lowest position.In addition, we did not observe any obstruction of the valve, flow always remained possible.Obstruction is a known complication of a shunting system.It is described in our instructions for use.It can appear at any stage of the shunt, including for instance the catheters.We can however not make a clear affirmation as the rest of the shunting system has not been returned to us.

Event Description

A patient suffered from a dilatation of the ventricular system after implantation of the polaris valve.No alteration of the distal catheter to the valve system and intracranial catheter was observed during the surgical act, however without operating the system prior to the implantation.

• Brand Name: POLARIS
• Type of Device: POLARIS ADJUSTABLE 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: jean-christophe audras ; 5 rue guy moquet; orsay, 91400 ; FR 91400 ; 3169353500
• MDR Report Key: 5952057
• MDR Text Key: 55138633
• Report Number: 3001587388-2016-16322
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 03760124131314
• UDI-Public: 3760124131314
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K141227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/01/2020
• Device Model Number: SPVA-2010
• Device Catalogue Number: SPVA-2010
• Device Lot Number: C0275
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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): Required Intervention