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

Catalog Number	823162
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2025
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
The physician reported a hakim valve (id 823162) was implanted via ventriculoatrial (va) shunt on an unknown date with an unknown setting.The valve was used with a ventricular catheter (id 823041), and no issue was reported with the catheter.Cerebrospinal fluid overdrainage occurred, and the patient developed slit ventricle syndrome.The pressure setting was 80mmh2o at that time.The patient was hospitalized, and the setting was changed to 100mmh2o.Due to the recurrence of hydrocephalus, the pressure setting was changed to 90mmh2o.The patient¿s condition stabilized, so he/she was discharged.Then, the patient was hospitalized again due to the recurrence of hydrocephalus.The patient¿s condition improved without changing the pressure setting.The doctor assumed that the device was having pressure setting alteration issues.The device was explanted and replaced with a new device on (b)(6) 2025.Based on the information provided, it is unknown if the patient presented signs and symptoms due to slit ventricle syndrome.It is also unknown if the catheter was removed or replaced.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the lot 3926176 conformed to the specifications when released to stock.Failure analysis -the position of the cam when valve was received was on setting 140 mmh2o.The valve was visually inspected; no defect was noted.The valve was visually inspected; no defect was noted.The valve passed the test for occlusion, leak and reflux.The valve was not pressure tested.The valve failed the test for programming.The valve was visually inspected under microscope at appropriate magnification: biological debris were found on the motor.Traces of corrosion have been identified on stator.A visual control magnetizing engines was done; a normal polarization was noted.Root cause analysis - the root cause for the problem reported by the customer could be due to the corrosion of the mechanism linked to the accumulation of biological debris which has weakened and destroyed the mechanism.The root cause for the programming issue is due to biological debris and 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: 21941519
• Report Number: 3013886523-2025-00087
• Device Sequence Number: 12899962
• Product Code: JXG
• UDI-Device Identifier: 10886704041559
• UDI-Public: (01)10886704041559(17)240630(10)3926176
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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: 823162
• Device Lot Number: 3926176
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2019
• 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