MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSVII LP TWO PIECE SHUNT SYSTEM WITH UNITIZED 11

Catalog Number 909712P

Device Problems Device Inoperable (1663); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2015

Event Type  malfunction  

Event Description

The valve was implanted using the standard implant technique.Following insertion of the shunt, the surgeon was unhappy with the profile of the antechamber and valve mechanism.The valve failed the patency test and no cerebrospinal fluid (csf) would be aspirated through the valve to the distal catheter.There was no patient injury.However, the event led to increase surgery time for 60 minutes.The patient was not harmed due to the increase of surgery time.The medical staff finished the procedure by implanting a competitor product.Patient outcome was good.

Manufacturer Narrative

Integra has completed their internal investigation on 01/04/2016.The investigation included: methods: evaluation of actual device ; review of device history records; review of complaints history.Results: the valve unit only was received.Distal catheter had been cut and the stopper plate was slightly displaced.The valve modulus was then removed from its silicone elastomer housing and observed under magnification.Brownish residues were found at the level of the diaphragm, in the seat lodging.Those residues and their location may explain the higher observed flow.The device history records of ref (b)(4), lot 0190293, valve sn (b)(4) were reviewed and did not reveal any anomaly.The batch was manufactured in april 2015 and included (b)(4) valves.No similar complaint was received for a product from this batch.The integra complaint database for the osv ii valves was reviewed for the last 3 years.The review indicated the rate of complaint reports for failure/obstruction during the implantation procedure is (b)(4) (basis of (b)(4) osv ii valves).Conclusion: the complaint is not verified by the device investigation: the valve is found patent.However, since residue were observed in the valve mechanism, it is possible that they first led to the valve obstruction during the implantation procedure, and then were slightly displaced during valve manipulations or decontamination, explaining the slight shift at the flow regulation stage.Each valve is pressure/flow tested at the end of the manufacturing process and valve (b)(4) was within specifications.The integra complaint database for the device was reviewed for the last 3 years.The review indicated the rate of complaint reports for failure/obstruction during the implantation procedure is (b)(4) (basis of (b)(4) osv ii valves).Valve obstruction is a known complication valve therapy: it may be related to debris released during the implantation procedure.The instructions for use recommend to aspirate 2 or 3ml of csf from the ventricular catheter to eliminate possible debris from the csf.No further investigation nor corrective action is therefore deemed required.

• Brand Name: OSVII LP TWO PIECE SHUNT SYSTEM WITH UNITIZED 11
• Type of Device: OSVII
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5217906
• MDR Text Key: 31143122
• Report Number: 9612007-2015-00020
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K140722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 909712P
• Device Lot Number: 0000000190293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 9 YR