MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG

Catalog Number 828806

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebral Ventriculomeglia (2133)

Event Type  Injury  

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 Description

A physician reported a codman certas plus programmable in-line valve was implanted in a patient after a subarachnoid hemorrhage via a lumbar peritoneal shunt on (b)(6) 2021 with an initial setting of 4.The valve was used with the silascon lumbar catheter (manufactured by kaneka, product code: 702-jj).Ventricular enlargement was suspected due to gait disturbance, and when the set pressure was changed to setting 2 on (b)(6) 2021 the symptoms did not change.Due to patient disorientation on (b)(6) 2021 a brain mri was performed and ventricular enlargement was confirmed.The pressure was changed to a setting of 1.Ventricular enlargement improved.Due to patient disorientation on (b)(6) 2021 a brain mri was performed and ventricular enlargement was confirmed.Flushing was performed without an improvement in clinical symptoms.The patient was taken to the operating room for a shunt revision and the valve was removed and replaced on (b)(6) 2021.The patient is in the follow up.No further information was provided by hospital.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.The valve was returned for evaluation: failure analysis: the position of the cam when valve was received was at setting 1.The valve was visually inspected; needle holes in the needle chamber were noted.The valve was hydrated per internal process.The valve was leak tested and only leak from the needle holes in the needle chamber.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve, at the time of investigation the no functional issues were noted.

Event Description

N/a.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12104847
• MDR Text Key: 263826051
• Report Number: 3013886523-2021-00278
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• 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: 09/29/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 828806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/01/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR