MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA OSVII

Catalog Number XXX- OSVII

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 09/03/2018

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned to the manufacturer for analysis; customer had discarded the device.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

The (b)(6) female patient had an osvii valve (specific product id not specified) implanted on (b)(6) 2018.On (b)(6) 2018, the patient underwent an externalization of the ventriculopleural shunt at the level proximal to the osv valve; exclusion of the osv valve from the system.Information via surgery operative notes indicated that the osv ii had failed to bring the ventricular catheter to normal size.The pressures of the osv ii valve were measured and it was found that the valve that was presented with the column of 30 cm of water would close the system at 7.5 cm of water.Since by previous measurements, it was known that the patient had an intracranial pressure (icp) with dilated ventricles at 80mm of water.It was decided to externalize the shunt and bypass the valve that was left inside and occluded proximally.The osv valve was not removed during this (b)(6) 2018 surgery.On (b)(6) 2018, the patient had the old valve and ventriculopleural shunt removed and replaced with a new ventriculoperitoneal shunt and valve (meithke pasv2).The osv valve was not saved.The customer stated they could not determine that it was a device failure or it may have been related to the patient's underlying condition requiring a different device.

Manufacturer Narrative

The device was not returned for evaluation.No device history record could be performed as no traceability information is available.The hospital reported an osv ii valve was not efficient in reducing ventricular size and was explanted 12 days after implantation, in a patient with severe subarachnoid hemorrhage and a history of 2 previous other shunts implanted and failing within 3 weeks.Hospital stated ¿we can¿t determine that is was a failure and may have been related to the patient¿s underlying condition requiring a different device¿.Each valve is pressure/flow tested at time of manufacturing.No device is available for investigation, the complaint is unverifiable and its exact root cause could not be determined.Early underdrainage is a known complication of valve therapy, as stated in the product instructions for use.

• Brand Name: OSVII
• Type of Device: OSVII
• 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: 8039530
• MDR Text Key: 126219705
• Report Number: 9612007-2018-00032
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K140722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX- OSVII
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VENTRICULOPLEURAL SHUNT
• Patient Age: 47 YR