MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSVII VALVE UNIT, 2 CONNECTORS WITH ANTECHAMBER

Catalog Number 909700

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2017

Event Type  malfunction  

Event Description

The shunt was removed as it did not function.Additional information received on 21mar2017 with the following: there was no patient injury reported.The event did not lead to increase surgery time.The patient had slow dilatation of ventricle; the cause of insufficient drainage of csf flow.No other information provided.

Manufacturer Narrative

Additional information received on april 10th 2017 : the date of valve implantation was unknown.The patient is a (b)(6) female with an underlying medical condition of multiple meningitis and "hamartoma of mesencephalon".

Manufacturer Narrative

Integra has completed their internal investigation on may 3, 2017 results: evaluation of returned device; patency testing showed the received valve was patent (no obstruction).The valve was tested and found within pressure/flow specifications.Each osv ii valve is pressure/flow tested at the end of the manufacturing process.The involved valve osv ii ref 909700, sn (b)(4) was tested within pressure/flow specifications at time of manufacture.Dhr review; the device history records review of the osv ii valve ref 909700, lot # 0188400, s/n (b)(4) were reviewed and did not reveal any anomaly.Complaints history; upon review of integra¿s complaint system from january 2014 ¿ march 24, 2017, a total of nine (9) complaints (including this one) for osv ii valve systems have been reported for obstruction after the implantation procedure.Over (b)(4) units of osv ii valve systems have been sold from january 2014 to march 6, 2017, resulting in a complaint occurrence rate of approximately (b)(4).No adverse trend is observed.Conclusion: as the received valve was found within pressure/flow specifications, the complaint is not verified: the valve testing does not explain the reported obstruction.Given the available information, the exact root cause of this event could not be determined.

• Brand Name: OSVII VALVE UNIT, 2 CONNECTORS WITH ANTECHAMBER
• 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: 6435373
• MDR Text Key: 71217751
• Report Number: 9612007-2017-00007
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 909700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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