MAUDE Adverse Event Report: SOPHYSA POLARIS; POLARIS ADJUSTABLE VALVE

Model Number SPVA-2010

Device Problems Device Difficult to Program or Calibrate (1496); Device Operates Differently Than Expected (2913); Reset Problem (3019)

Patient Problem Hydrocephalus (3272)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

Waiting for the device to be returned for investigation.

Event Description

Patient with hydrocephalus by obstructions in foramen of luschka was implanted with a polaris valve in (b)(6) 2014.The patient remained well until (b)(6) 2015 when the typical symptoms of hydrocephalus was observed, the ct showed re-occurence of hydrocephalus.The valve not remained the setted pressure and the valve was replaced in (b)(6) 2015 with a new polaris valve with the initial setting of 110mm h2o.In (b)(6) 2016, the patient presented headache and disequilibrium and the doctor found the valve pressure was set to 30mm h2o.The doctor changed the setting back to 110mm h2o and the patient returned in follow up visit (2days -1week later) showing a reset to 50mm h2o.The valve was reset to 150mm h2o and was again found to auto change to 50mm h2o during follow-up visit.This happened 4 times and the patient was admitted to hospital to ensure being away from any external magnetic medium that could change the setting.The valve was set by the doctor to 110mm h2o and the next day, the pressure setting was shown to be back to 70mm h2o/ and the patient showed symptoms of overdrainage (collapse of ventricles) and the patient is prescribed to explant the valve and to be replaced by a new drainage system.

Event Description

Patient with hydrocephalus by obstructions in foramen of luschka was implanted with a polaris valve in (b)(6) 2014.The patient remained well until (b)(6) 2015 when the typical symptoms of hydrocephalus was observed, the ct showed re-occurrence of hydrocephalus.The valve not remained the setted pressure and the valve was replaced in (b)(6) 2015 with a new polaris valve with the initial setting of 110mmh2o.In (b)(6) 2016, the patient presented headache and disequilibrium and the doctor found the valve pressure was set to 30mmh2o.The doctor changed the setting back to 110mm h2o and the patient returned in follow up visit (2 days -1week later) showing a reset to 50mmh2o.The valve was reset to 150mmh2o and was again found to auto change to 50mmh2o during follow-up visit.This happened 4 times and the patient was admitted to hospital to ensure being away from any external magnetic medium that could change the setting.The valve was set by the doctor to 110mmh2o and the next day, the pressure setting was shown to be back to 70mmh2o/ and the patient showed symptoms of overdrainage (collapse of ventricles) and the patient is prescribed to explant the valve and to be replaced by a new drainage system.

Manufacturer Narrative

The testing performed in our laboratory showed adjustments difficulties, but nothing, in the visual or functional controls performed on the valve, could explain this situation.We could not recreate the issue encountered by the user as we did not observe any deprogramming of the valve.In addition, no x-ray image was sent to confirm the adjustment of the valve and there is no certainty that the compass designed for the reading and adjustment of polaris valves was used to verify the setting values.The difficulties observed with the adjustment of the rotor might explain the situation faced by the user.The laboratory testing performed indeed revealed some difficulties to adjust the pressure.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 not a case of deprogramming, but of 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 Description

Patient with hydrocephalus by obstructions in foramen of luschka was implanted with a polaris valve in (b)(6) 2014.The patient remained well until (b)(6) 2015 when the typical symptoms of hydrocephalus was observed, the ct showed re-occurrence of hydrocephalus.The valve not remained the settled pressure and the valve was replaced in (b)(6) 2015 with a new polaris valve with the initial setting of 110mmh2o.In (b)(6) 2016, the patient presented headache and disequilibrium and the doctor found the valve pressure was set to 30mmh2o.The doctor changed the setting back to 110mm h2o and the patient returned in follow up visit (2days -1week later) showing a reset to 50mmh2o.The valve was reset to 150mmh2o and was again found to auto change to 50mmh2o during follow-up visit.This happened 4 times and the patient was admitted to hospital to ensure being away from any external magnetic medium that could change the setting.The valve was set by the doctor to 110mmh2o and the next day, the pressure setting was shown to be back to 70mmh2o/ and the patient showed symptoms of overdrainage (collapse of ventricles) and the patient is prescribed to explant the valve and to be replaced by a new drainage system.

• 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: 5771541
• MDR Text Key: 49766823
• Report Number: 3001587388-2016-16251
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K031097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/01/2019
• Device Model Number: SPVA-2010
• Device Catalogue Number: SPVA-2010
• Device Lot Number: B0460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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): Other