MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR UNKNOWN CERTAS PLUS VALVE

Catalog Number XXX-CERTAS PLUS VALVE

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

The certas valve (id unknown) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed. The root cause(s) of the reported issue could not be determined; however, a possible root cause for the ¿shunt failure. ¿ could be due to biological debris and protein build up interfering with the valve mechanism. 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.

Event Description

This is 2 of 2 reports linked to mfg report number: 3013886523-2022-00055. A physician reported a certas valve (unknown id) was implanted in a (b)(6) female via l-p shunt on (b)(6) 2019 with unknown setting. Due to shunt failure, a hakim v-p shunt (id 823842) was added on (b)(6) 2021. The v-p shunt pressure was reduced to 30 mmh2o and the patient was in the follow up. A year later, hydrocephalus was confirmed by ct and on (b)(6)2022, the hakim valve (id 823842) was removed and replaced.

• Brand Name: UNKNOWN CERTAS PLUS VALVE
• 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: 13722207
• Report Number: 3013886523-2022-00082
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: XXX-CERTAS PLUS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Patient Age: 41 YR
• Patient Sex: Female