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

Catalog Number	823162
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id 823162) was implanted due to congenital hydrocephalus via ventriculoperitoneal (vp) shunt on unknown date with unknown setting.The device was removed and replaced on (b)(6) 2024 due to shunt dysfunction.According to information provided, it is unknown if the patient presented signs and symptoms due to shunt dysfunction.Primary disease: slit ventricle syndrome.
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
The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the product code 82-3162 with lot cthbj5, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 180 mmh2o.The valve was visually inspected, the cam mechanism wiggled.The valve passed the test for leak and reflux.The valve failed the test for programming and occlusion.The pressure test could not be performed as the device could not be programmed.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris was found on the ruby ball, motor and on the seat of the ruby ball.The stator was also dislodged.Root cause analysis - the root cause for the shunt dysfunction issues is due to biological debris and protein build up interfering with the valve or stator dislodges due to galvanic corrosion.
Event or Problem Description
N/a.

• 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: 20926262
• Report Number: 3013886523-2024-00387
• Device Sequence Number: 5129427
• Product Code: JXG
• UDI-Device Identifier: 10886704041559
• UDI-Public: (01)10886704041559(17)200531(10)
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 04/04/2025

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 Expiration Date: 05/01/2020
• Device Catalogue Number: 823162
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• 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