MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV ONLY; CERTAS PLUS

Catalog Number 828800

Device Problem Mechanical Problem (1384)

Patient Problem Hematoma (1884)

Event Date 10/10/2023

Event Type  Death  

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 facility reported a certas valve (id 828800) was unable to be "turned off".Surgeon was unable to change the setting to 8, x-ray showed the setting between 7 and 8, the surgeon tied the distal catheter to prevent drainage however, the patient died.The patient suffered a traumatic brain injury (tbi) and then after a sub dural haematoma which led to death.The valve was implanted in (b)(6) 2022.

Manufacturer Narrative

Certas valve (828800) was not returned for evaluation (as per customer, product not available); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.However, a possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the device.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.A medical assessment was requested to medical safety department with conclusion: there is no confirmation of a device related event.There has been no device return and no further information has been received from integra requests.The patient was noted to have been admitted to hospital with a traumatic brain injury and subsequent subdural hematoma, approximately one year status post valve implantation to treat hydrocephalus.At this time, the certas valve was programmed and noted to have been in the 7-8 positions.The doctors decided to tie off the distal catheter to prevent all drainage.Supportive documentation indicated that "there was no concern that the device had contributed to the death of the patient.".

Event Description

N/a.

• Brand Name: CERTAS INLINE VLV ONLY
• Type of Device: CERTAS PLUS
• 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 ; 6099362319
• MDR Report Key: 18243037
• MDR Text Key: 329428025
• Report Number: 3013886523-2023-00399
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 828800
• Device Lot Number: 6308700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/08/2024
• Date Device Manufactured: 05/02/2022
• 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
• Patient Outcome(s): Death
• Patient Sex: Male