MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL VLV ONLY; CERTAS PLUS SMALL & RA

Model Number	828810PL
Medical Device Problem Codes	Obstruction of Flow (2423); Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A facility reported a certas valve (id 828811pl) was implanted on (b)(6) 2022 with setting 1 (25 mmh20).During the clinic checkup the valve was found to be "stuck".There were several attempts to change the valve to the desired setting.A decision was made to explant the valve and test the components to find the cause of the issues.Ventricular catheter was occluded.The valve had some blockage and manometer was closed around 85 mmh2o (high for setting 1 probably a result of catheter occlusion).The valve was explanted and tested at 25mmh2o.A new valve was implanted at setting 3 (80 mmh2o).
Additional Manufacturer Narrative
The certas valve (828810pl) was not returned for evaluation after the three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause 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 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 or Problem Description
N/a.

• Brand Name: CRTS SM IL VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA
• 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: 16312098
• Report Number: 3013886523-2023-00028
• Device Sequence Number: 14985483
• Product Code: JXG
• UDI-Device Identifier: 10381780529316
• UDI-Public: (01)10381780529316(17)251231(10)5191829
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: 828810PL
• Device Catalogue Number: 828810PL
• Device Lot Number: 5191829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/29/2023
• Date Device Manufactured: 01/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown