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

Catalog Number	823832
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2025
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 (id 823832) was implanted via a left ventriculoperitoneal (vp) shunt on (b)(6) 2025, due to hydrocephalus, coma, and decompressive craniotomy for cerebral hemorrhage.The initial pressure was set at 180 mm h2o.On (b)(6), the pressure was adjusted to 200 mm h2o; however, x-ray verification showed only 70 mm h2o.Multiple adjustments under x-ray guidance were required to finally achieve the intended pressure of 200 mm h2o.A suspected valve malfunction was believed to have caused the adjustment difficulties.On (b)(6), the patient's condition deteriorated due to unresolved hydrocephalus, necessitating another pressure adjustment.X-ray verification again showed failure to reach the preset pressure, and four attempts were required under x-ray to finally achieve 160 mm h2o.Due to clinically confirmed unreliable pressure adjustment, a valve revision surgery was performed on june 26, during which the valve was replaced with the same model.There was no information available indicating whether the patient experienced any signs or symptoms directly attributable to the product issue.The procedure was successful, and the patient remained under medical observation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823832) was returned for evaluation.Device history record (dhr) - the product code 82-3832 with lot 7330009, pdtk42 conformed to the specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at setting 40 mmh2o.The valve was visually inspected; no defect was noted.The valve passed the test for programming, occlusion, leak, reflux and siphon guard.The valve was then pressure tested according to test method; the valve failed the test (pressure results are closed to specification).The valve was dismantled and examined under microscope at appropriate magnification: biological debris was noted on the ruby ball.Root cause analysis - the issue reported by the customer is not confirmed.The probable root cause could be due to human misuse.The root cause for pressure issue observed during investigation is due to biological debris observed on the ruby ball: protein build up interfering with the valve in view of the biological debris found during the investigation.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• 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: 22521057
• Report Number: 3013886523-2025-00186
• Device Sequence Number: 15468573
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)281130(10)7330009
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 823832
• Device Lot Number: 7330009
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2023
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian