MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE RIGHT ANGLE; CHPV

Catalog Number	823184
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/15/2025
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 facility reported a hakim valve was implanted on (b)(6) 2025.Revision surgery was required due to valve failure resulting in acute hydrocephalus.No additional information has been provided after several attempts.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve was returned for evaluation: dhr - lot cvfbv8 conformed to the specifications when released to stock.Failure analysis - the valve failed the tests for programming and pressure.The valve was visually inspected; no defect was noted.The valve passed the tests for occlusion, leak, and reflux.The valve was dismantled and examined under microscope at appropriate magnification: biological debris was noted on the housing.Root cause - the possible root cause for programming and reported issue could be due to biologicals debris observed in the housing.As mentioned in the ifu : accumulation of biological matter within the valve can: - cause difficulties adjusting the valve setting with the tool kit - impair the anti-reflux function.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Root cause update: the root cause for the programming and reported issue could be due to biologicals debris observed on the housing, as noted in the ifu: accumulation of biological matter (i.E.Blood, protein accumulations, tissue fragments, etc.) in the programming mechanism can cause inability of the device to be reprogrammed.Clogging of the programmable valve with biological matter can cause the valve to become unresponsive to attempts to change the pressure setting.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE RIGHT ANGLE
• Common Device Name: CHPV
• 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: 22809217
• Report Number: 3013886523-2025-00210
• Device Sequence Number: 12999737
• Product Code: JXG
• UDI-Device Identifier: 10886704041580
• UDI-Public: (01)10886704041580(17)210331(10)CVFBV8
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 823184
• Device Lot Number: CFVBV8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 10/10/2025; 12/11/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/27/2025; 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2016
• 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 Sex: Unknown