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

Catalog Number XXX-CERTAS PLUS VALVE

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

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 certas valve was implanted via l-p shunt in (b)(6) 2020 with unknown setting.Due to suspicion of obstruction, the valve was removed and replaced on (b)(6) 2021.It is unknown if the patient experienced any signs and symptoms.Patient status was unknown.

Event Description

N/a.

Manufacturer Narrative

The certas valve 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, 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 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.

• 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: 15156678
• MDR Text Key: 297149717
• Report Number: 3013886523-2022-00361
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CERTAS PLUS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• 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 Age: 81 YR
• Patient Sex: Male