MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSVII CONNECTOR WITH ANTECHAMBER.

Model Number	909712
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that the osv ii valve (909712) was not draining and the patient was starting to go blind from both eyes.Further information received indicates that the valve was explanted due to it being blocked, and the increased icp (intracranial pressure) led to weakened optic nerves and impacted vision.No additional information has been made available.
Additional Manufacturer Narrative
The 909712 (osv ii) was returned for evaluation: device history record (dhr): the dhr was reviewed and did not reveal any anomalies associated with the reported failure.Failure analysis - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.The valve was received with visible brownish residues in the valve¿s core.Valve was completely obstructed (impossible to fill it with water).Valve modulus was removed from its silicone elastomer housing: brownish residue were present at the valve outlet and on the bottom lid once removed.Valve modulus was opened and inspected under magnification: residues were found in a large quantity inside the valve and between the pin and seat, impairing the valve mechanism.Root cause analysis - the complaint is verified, as the received valve was obstructed due to residue adhering to the valve' s mechanism.The 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 as stated in the device instructions for use (ifu).Obstruction may be related to debris released during the implantation procedure (early obstructions).The ifu recommends to aspirate 2 or 3ml of csf from the ventricular catheter to eliminate possible debris from the csf.Obstruction may also be related to patient's physiological conditions (early or late obstructions).Complaints analysis does not reveal any adverse trend regarding osv ii valve underdrainage/obstruction.No further investigation nor corrective action is therefore deemed required.

• Brand Name: OSVII CONNECTOR WITH ANTECHAMBER.
• Common Device Name: 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: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14674988
• Report Number: 9612007-2022-00011
• Device Sequence Number: 20180458
• Product Code: JXG
• UDI-Device Identifier: 10381780034032
• UDI-Public: 10381780034032
• Combination Product (Y/N): N
• PMA/510(K) Number: K971799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2022
• Device Model Number: 909712
• Device Catalogue Number: 909712
• Device Lot Number: 0216959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown