MAUDE Adverse Event Report: SOPHYSA POLARIS; POLARIS ADJUSTABLE VALVE

Model Number	SPVA-2010
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/13/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: POLARIS ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 5952057
• Report Number: 3001587388-2016-16322
• Device Sequence Number: 839294
• Product Code: JXG
• UDI-Device Identifier: 03760124131314
• UDI-Public: 3760124131314
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K141227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2016

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
• Operator of Device: Physician
• Device Expiration Date: 04/01/2020
• Device Model Number: SPVA-2010
• Device Catalogue Number: SPVA-2010
• Device Lot Number: C0275
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2016
• Supplement Report FDA Received Date: 11/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention