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

Catalog Number	823832
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id (b)(6)) was implanted on (b)(6) 2025.After the procedure, there was no improvement in the patient's ventricle, it did not shrink.On (b)(6) 2025, the physician adjusted the valve pressure to 140 mmhg, but the ventricle showed no change.An x-ray on (b)(6) 2025 revealed that the valve was unable to be programmed to the set pressure.On (b)(6) 2025, the physician removed and replaced the valve with a new device.After the revision procedure, the patient had an x-ray check, and the valve has been programmed to the setting pressure.No information is available if the patient experienced any signs or symptoms.The patient is stable.
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
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 7286641, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 120 mmh2o.The valve was visually inspected; no defect was noted.The valve was hydrated.The valve passed the test for programming, occlusion, leak, reflux, siphon guard and pressure.The valve functions.Root cause analysis - no root cause could be determined for the failure issue reported by the customer as the technician could not confirm any problems with the valve at the time of investigation.The possible root cause could be due to biological debris and protein build up interfering with the valve mechanism, as seen in the investigation report no programming issues were noted 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: 21721030
• Report Number: 3013886523-2025-00058
• Device Sequence Number: 9590754
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)280831(10)7286641
• 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): 05/14/2025

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: 823832
• Device Lot Number: 7256926
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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: 88 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian