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

Catalog Number	828814PL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Vomiting (2144); Lethargy (2560)
Date of Event	11/04/2024
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 (unknown id) was implanted on (b)(6) 2024, in a 3-year-old female patient.The patient slipped and hit the head on the hardwood floor closed to the implanted shunt.After two to three hours, shunt failure symptoms were noticed such as lethargy and vomiting.Therefore, the valve was removed and replaced on (b)(6) 2024.There were no visible cracks or blockage noticed however, there was a blood in the siphonguard.
Additional Manufacturer Narrative
Updated fields: d1, d2a, d2b, d4, d9, g3, g6, h2, h3, h4, h6, h11.The certas valve (id 828814pl) was returned for evaluation.Failure analysis - the position of the cam when valve was received was on setting 7.The valve was visually inspected, and no defect observed.The valve failed the test for programming, occlusion, siphon guard and pressure.The valve passed the test for leak and reflux.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification, biological debris was found on the ruby ball, motor and on the seat of the ruby ball.Root cause analysis - the root cause for the shunt failure is due to biological debris and protein build up interfering with the valve.
Event or Problem Description
N/a.

• Brand Name: CRTS SM IL SG VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA W/SG
• 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: 20757299
• Report Number: 3013886523-2024-00369
• Device Sequence Number: 8561076
• Product Code: JXG
• UDI-Device Identifier: 10381780529378
• UDI-Public: 10381780529378
• Combination Product (Y/N): N
• PMA/510(K) Number: K223330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 05/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 828814PL
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 05/05/2025
• 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: 3 YR
• Patient Sex: Female
• Patient Weight: 16 KG
• Patient Race: Black Or African American