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

Catalog Number	828811PL
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
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 physician reported a certas valve (id 828811pl) was implanted on (b)(6) 2016, with a setting 4.On (b)(6) 2017, the patient setting was set to 5.The patient had magnetic resonance imaging (mri) on (b)(6) 2023 and was set at 5.On (b)(6) 2025, the patient had a cranial mri for a 2-year follow-up.However, the shunt was moved and set at 8.They were unable to set the valve to 5.Therefore, a reprogramming was done under fluoroscopy, and the shunt was still set to 8.Due to the issue, the valve was removed and replaced on (b)(6) 2025.The patient did not experience any signs or symptoms due to the product issue.The patient condition is stable.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The certas valve (id 828811pl) was returned for evaluation.Failure analysis: the position of the cam when valve was received was at setting 8.The valve was visually inspected; 1 suture attached on the lateral part.The valve irrigated and no defect was noted.The valve was hydrated.The valve failed the test for programming.The valve passed the test for occlusion, leak, reflux, and pressure at setting 8.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the rotating construct.Root cause analysis: the root cause for the issue reported by the is due to biological debris and protein build up interfering with the valve, at the time of investigation, biological debris were found and as mentioned in the instruction for use (ifu): "accumulation of biological matter within the valve can: cause difficulties adjusting the valve setting with the tool kit".
Event or Problem Description
N/a.

• Brand Name: CRTS SM IL VLV W CATH ACC
• 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 08540 ; 6099362319
• MDR Report Key: 22159991
• Report Number: 3013886523-2025-00129
• Device Sequence Number: 7266134
• Product Code: JXG
• UDI-Device Identifier: 10381780535904
• UDI-Public: 10381780535904
• Combination Product (Y/N): N
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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 Catalogue Number: 828811PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White