MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV W CATH ACC; INTERNAL CSF DRAINAGE

Catalog Number	828815PL
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
1 of 2 reports (same event/different products).Other mft report number: 3014334038-2026-00038.A physician reported a certas valve was placed on (b)(6) 2025.The physician experienced issues checking the valve setting and programming it with the electronic programmer (id (b)(6)).On (b)(6) 2026, they tried to adjust the valve; however, the electronic programmer did not appear to change.The physician wanted to move it from 7 to 8, but it would not move.It is possible the valve malfunctioned and became stuck and unable to program.It is also possible there was an issue using the electronic programmer (a magnet could have been interfering or something else could be wrong with the programmer).The placement of the valve for this patient was also a little more difficult since it was more behind the ear than on the top of the head.Out of caution and to address the patient¿s concern, the valve was removed and replaced.The patient did not experience any specific symptoms prior to replacing the valve.The patient is doing well.The patient is human immunodeficiency virus (hiv) positive.The electronic programmers were tested using a demo shunt, and they all worked well.However, it was noticed that the plastic facing on the programmer has shifted and impacts turning the magnet.It is not known if they were dropped or what caused this.Note from integra: two different dates were provided for valve explantation ((b)(6)).Request for clarification was send; however, we haven't received a response.If provided, it will be included in the follow-up report.
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
N/a.
Additional Manufacturer Narrative
The certas valve (id 828815pl) was returned for evaluation: failure analysis - the position of the cam when valve was received was at setting 5.The valve was visually inspected; the ventricular connector was slightly bent.The valve was hydrated.The valve passed the test for programming, occlusion, leak, reflux, siphon guard and pressure.The catheter was tested; no occlusion was noted.The siphon guard was removed.The valve functions.Root cause analysis - no root cause could be determined as the technician could not confirm any problem at the time of investigation.The possible root cause for the issue reported by the customer, could be due to biological debris occluding the valve (observed on the housing) as noted on the ifu: cause difficulties adjusting the valve setting with the tool kit and impair the anti-reflux function.Complications of implanted shunt systems include mechanical failure, shunt pathway obstruction, infection, foreign body (allergic) reaction to implants, and csf leakage along the implanted shunt pathway.Clinical signs such as headache, irritability, vomiting, drowsiness, or mental deterioration might be signs of a nonfunctioning shunt¿ additional information: the valve was removed on (b)(6) 2026.

• Brand Name: CRTS SM IL SG VLV W CATH ACC
• Common Device Name: INTERNAL CSF DRAINAGE
• 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: 25330477
• Report Number: 3013886523-2026-00123
• Device Sequence Number: 13242522
• Product Code: JXG
• UDI-Device Identifier: 10381780535966
• UDI-Public: 10381780535966
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 828815PL
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 07/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ELECTRONIC PROGRAMMER (ID (B)(6)),; ELECTRONIC PROGRAMMER (ID 828852)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 152 LB
• Patient Race: White