MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSV II LOW PRO

Catalog Number 909712P

Device Problem Pressure Problem (3012)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that a premature baby ((b)(6) uncorrected) with a post-hemorrhagic hydrocephalus internus was implanted with osv2 ii low pro valve system on (b)(6) 2020.It initially had a drain with a reservoir, which had to be punctured regularly.All signs of intracranial pressure quickly developed again (bulging fontanel, restlessness, sleepiness, vomiting, reluctance to drink, etc.).Therefore revision surgery with a new ventriculo-peritoneal shunt (again osv ii low pro valve system and separate ventricular catheter)was necessary because the valve was not regulating and the pressure was rising to 40.Subsequently, the drainage system was sufficient and the child had a relaxed fontanel and became stable.

Event Description

N/a.

Manufacturer Narrative

The low pro valve (909712p) was received for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies related to the reported failure was observed.Failure analysis - the valve was received without its distal catheter.Patency test with water showed resistance.Visual inspection under magnification revealed no anomaly.The valve was pressure/flow tested and found out of specifications (valve partially obstructed).A second pressure/flow test that involved a second valve flushing and filling, showed an opening pressure higher than expected and a flow regulation that was lower than manufacturer specifications.The valve modulus was removed from its silicone elastomer housing, opened and inspected under magnification: residues, that looked like proteinaceous matter, were observed in the valve mechanism, around the pin.Root cause -the complaint is verified, the received valve was partially obstructed, due to residue adhering to the valve' s mechanism.This valve was tested within pressure/flow specifications at the end of its manufacturing process, as shown on the device history records.Valve obstruction is a known complication valve therapy: such early shunt obstructions may be related to the surgical technique (blood and debris introduced in the shunt at insertion time), or to patient physiological conditions (csf characteristics).Trends are being monitored for this and similar issues.No further investigation nor corrective action is deemed required at this time.

• Brand Name: OSV II LOW PRO
• Type of Device: OSV II LOW PRO
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• MDR Report Key: 11047537
• MDR Text Key: 222707455
• Report Number: 9612007-2020-00024
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K971799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Catalogue Number: 909712P
• Device Lot Number: 0217216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1