MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA GRAVITY COMPENSATING ACCESSORY,MEDIUM; ANTI-SIPHON DEVICE

Catalog Number 903435

Device Problems No Device Output (1435); Use of Device Problem (1670)

Patient Problems Ambulation Difficulties (2544); Hydrocephalus (3272)

Event Date 09/14/2016

Event Type  Injury  

Event Description

On (b)(6) 2016 a (b)(6) female patient had the 903435 gravity compensating accessory implanted along with a fixed pressure valve.In the weeks following this surgery, specifically around (b)(6) 2016 the patient was experiencing difficulty with her gait and a scan was performed.The scanner detected hydrocephalus, suggesting that the gravity compensating accessory was not allowing the cerebrospinal fluid (csf) to drain.To solve this situation, it was necessary to surgically remove the gravity compensating accessory and implant a programmable valve.This took place on (b)(6) 2016.The programmable valve was a polaris spva valve, manufactured by sophysa.The hydrocephalus has been stabilized.

Manufacturer Narrative

Investigation completed 3/01/2017.Method: -dhr review, -trend analysis, - failure analysis.The device history records review of the gca ref 903435, lot 193322 were reviewed and did not reveal any anomaly.The batch was manufactured in january 2016 and included (b)(4) products.No similar complaint was received for a product from this batch.A review of integra complaint tracking database since january 2014 revealed no other complaint.No trend is observed visual inspection under magnification of the gravity compensating accessory (gca) revealed no anomaly that could explain the reported blockage.The gca was pressure/flow tested in both horizontal and vertical positions and found within specifications.The complaint is not verified on the received gca, the device investigation does not allow to explain the reported obstruction.Conclusion: the gca is implanted in series with a hydrocephalus valve to control cerebrospinal fluid drainage from the cerebral ventricles to an appropriate drainage site.The gca is designed to counterbalance gravity¿s effects on the fluid column within the out¬flow (drainage) catheter of an implanted shunt system.The reported insufficient drainage, a few weeks after implantation, is linked to the system (valve + gca) and may be related to several reasons: as the gca was found within specifications, the insufficient drainage may be linked to the valve malfunction (or not suited to the patient), or to the choice of gca operating characteristics (too much resistance added).Obstruction of the hydrocephalus valve system (with antigravity system or not) is a known complication of valve therapy, as indicated in the gca instructions for use.

• Brand Name: GRAVITY COMPENSATING ACCESSORY,MEDIUM
• Type of Device: ANTI-SIPHON DEVICE
• 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: 6238512
• MDR Text Key: 64431907
• Report Number: 9612007-2017-00002
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K152897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 903435
• Device Lot Number: 0193322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 79 YR