MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE; CHPV

Catalog Number	823834
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id 823834) was implanted on (b)(6) 2024 and stop functioning after 10 months of implantation.The valve was removed and replaced.No patient consequences.
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.
Additional Manufacturer Narrative
Root cause update: no root cause could be determined as the technician could not performed all the tests.The root cause for the "programming" issue 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 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.The root cause for the missing needle guard, could be due to improper handling, as noted in the ifu.Do not fold or bent the valve, folding or bending might cause rupture of the silicone housing, needle guard dislodgement or occlusion of the fluid pathway.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve was returned for evaluation: dhr - lot 7422650, conformed to the specifications when released to stock failure analysis - the valve was visually inspected;the needle guard was missing and biological debris were noted inside the housing.The valve was tested for programming: the valve failed the test.The leak, reflux and pressure test could not be performed as the needle guard was missing.Root cause - no root cause could be determined as the technician could not performed all the tests.The root cause for the "programming" issue 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 ifu: "accumulation of biological matter within the valve can: cause difficulties adjusting the valve setting with the tool kit".The root cause for the missing needle guard, could be due to improper handling, as noted in the ifu.Do not fold or bent the valve, folding or bending might cause rupture of the silicone housing, needle guard dislodgement or occlusion of the fluid pathway.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Correction: follow-up #2 was sent with us regulatory awareness date (g3): 01/04/2026.The correct us regulatory awareness date is: 12/11/2025.

• Brand Name: PROG VALVE INLINE
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22872265
• Report Number: 3013886523-2025-00218
• Device Sequence Number: 13368126
• Product Code: JXG
• UDI-Device Identifier: 10381780535041
• UDI-Public: (01)10381780535041(17)290630(10)7422650
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/13/2026

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: 823834
• Device Lot Number: 7422650
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 01/04/2026; 01/13/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/24/2025; 01/02/2026; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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: 74 YR
• Patient Sex: Unknown