MAUDE Adverse Event Report: SOPHYSA POLARIS; POLARIS ADJUSTABLE VALVE

Model Number	SPVB
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
A (b)(6) patient presented shunt failure symptoms.The valve was adjusted on high pressure and the flow was excellent.The symptoms improved but recurred.The valve turned down from the original setting of 110 to 70.The valve was adjusted on high pressure and the proximal flow was good but an x-ray examination confirmed that the valve was set at 70.Patient was taken to the operating room.The valve was disconnected from the catheters and it showed a good proximal and distal flow.
Additional Manufacturer Narrative
The valve was analyzed and found compliant.We could not recreate the issue faced by the user.Upon return, the valve was adjusted on its second operating pressure.The user states that he tried to adjust it on the third position.X ray examination confirmed that the valve was adjusted on the second position, but no x-ray images were sent to confirm adjustment on the third position.Therefore, in the absence of x-ray image, we cannot be certain that the valve pressure was actually well-adjusted in the first place.It is very likely that the pressure remained on its initial setting all along and that the issue encountered by the user was in fact due to adjustment difficulties.The latter is well-known in the lifecycle of such products.The instruction for use delivered with each valve provides many details regarding the potential cases of adjustment difficulties and the suggested measures to prevent it.
Event or Problem Description
A (b)(6) patient presented shunt failure symptoms.The valve was adjusted on high pressure and the flow was excellent.The symptoms improved but recurred.The user believes that valve turned down from the original setting to a lower setting.The valve was adjusted on high pressure and the proximal flow was good but an x-ray examination confirmed that the valve was set at a lower position.Patient was taken to the operating room.The valve was disconnected from the catheters and it showed a good proximal and distal flow.

• Brand Name: POLARIS
• Common Device Name: POLARIS ADJUSTABLE VALVE
• Manufacturer (Section D): SOPHYSA; 5 rue guy moquet; orsay, 91400 ; FR 91400
• MDR Report Key: 6131919
• Report Number: 3001587388-2016-16467
• Device Sequence Number: 784266
• Product Code: JXG
• UDI-Device Identifier: 03760124131321
• UDI-Public: 3760124131321
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K141227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2017

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: 01/01/2019
• Device Model Number: SPVB
• Device Catalogue Number: SPVB
• Device Lot Number: B0077
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 01/02/2017
• 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
• Patient Age: 15 MO