MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSVII, CONNECTOR WITH ANTECHAMBER.; N/A

Model Number 909712

Device Problem Infusion or Flow Problem (2964)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/26/2021

Event Type  Injury  

Event Description

A facility reported that on (b)(6) 2021, an osvii valve (909712) was implanted for hydrocephalus (post tumor resection).After 3 days of implantation, the patient's hydrocephalus was not improved and a new emergency surgical intervention was required on (b)(6) 2021 to check the implanted valve.In the revision surgery, it was verified that the osvii valve was not draining the cerebrospinal fluid (csf).The medical team chose to replace the osvii valve with the codman hakim medium pressure and the csf drainage worked correctly.The surgery was performed following the manufacturer's guidelines.Patient had neurological worsening, increased ventricular ectasia, underwent reoperation, and as a result, her hospital stay increased by 7 days.Patient is showing improvement with the implantation of the new valve.

Manufacturer Narrative

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

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 osvii,connector antechamber (909712) was returned for evaluation: dhr review - the device history records of ref 909712, lot 217615, sn (b)(6), were reviewed and did not reveal any anomaly that could explain the reported event.Failure analysis - visual inspection of the valve under magnification revealed no anomaly.The valve was pressure/flow tested and found functional, but slightly over specification complaint reported the valve was not draining, however, the received valve investigation does not verify the complaint, valve is not obstructed and does not underdrain.Root cause analysis - the exact cause of the reported underdrainage of the valve could not be determined by the investigation.The received valve investigation does not verify the complaint, valve is not obstructed and does not underdrain.Ventricular catheter was not returned and may have been obstructed.Valve manipulations after explantation may explain the slight shift of the pressure/flow curve.Given the device analysis, no further investigation nor corrective action is deemed required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: OSVII, CONNECTOR WITH ANTECHAMBER.
• Type of Device: N/A
• 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: 12845043
• MDR Text Key: 281033181
• Report Number: 9612007-2021-00037
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780034032
• UDI-Public: (01)10381780034032
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: 909712
• Device Catalogue Number: 909712
• Device Lot Number: 0217615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2020
• 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