MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR OSV II

Catalog Number	909700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Nausea (1970); Vomiting (2144)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that approximately 6 months after implantation, the osv ii (909700) valve appeared to be malfunctioning.The patient began getting headaches, nausea, and vomiting, and the mri showed slit ventricles.The valve was revised and replaced with hakim programmable valve model 82-3162; the catheters were not revised.The surgeon could not see anything obviously wrong with the valve but was keen to have it sent off for investigation.The patient has been reported as stable.No surgical delay has been reported.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The osv ii valve (909700) was returned for evaluation: failure analysis - investigation showed that the packaging was not returned with the valve.The valve was inspected and pictures were taken of the ¿as received¿ valve then decontaminated per process.No defect was found upon visual inspection of the valve.Flow control test was performed and failed; the valve was reversed leakage tested and passed this test.However, the printed curves is outside the measurement interval.Root cause - the probable root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve or could be due to improper handling during the implantation.As noted in the ifu: do not over-pressurize the valve system.Excessive flushing pressures may lead to valve damage.Additionally, the symptoms reported by the customer corresponds to the side effects, as noted in the ifu: in addition to the risks associated with shunt system or component implantation, major complications include mechanical failure, such as tubing fracture, material deterioration with time, or shunt pathway obstruction, infection, immune system reaction to materials and csf leakage along the shunt pathway.System disconnection can lead to catheter migration into the atrium, peritoneum or lateral ventricles.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: OSV II
• Common Device Name: OSV II
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 17226250
• Report Number: 3013886523-2023-00195
• Device Sequence Number: 17936417
• Product Code: JXG
• UDI-Device Identifier: 10381780521631
• UDI-Public: 10381780521631
• Combination Product (Y/N): N
• PMA/510(K) Number: K971799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 909700
• Device Lot Number: 0228463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 58 YR
• Patient Sex: Female