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

Catalog Number	823832
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Coma (2417)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id: 823832) was implanted on (b)(6) 2025, via ventriculoperitoneal (vp) shunt.There was no improvement in ventricular size postoperatively, with accompanying mydriasis (pupil dilation).On (b)(6) 2025, a revision surgery was performed to replace the shunt with an alternative brand.Postoperative imaging showed normalized ventricles, though the patient remained comatose.An evaluation of the explanted device revealed abnormally slow flow rate at the shunt valve outlet.The patient became comatose on (b)(6) 2025; however, according to information provided, it is undetermined if the patient comatose state is due to valve failure.
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
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d8, d9, g6, h1, h2, h3, h4, h6, h8, h11.The hakim valve (id 823832) was returned for evaluation.Device history record (dhr) - the product code 82-3832 with lot 7225095, conformed to the specifications when released to stock.Failure analysis -the position of the cam when the valve was received was at setting 200 mmh2o.The valve was visually inspected; no defect was noted.The valve passed the test for programming, occlusion, reflux and siphonguard.The valve was leak tested and failed the test, leak from the needle chamber.The valve was then pressure tested, and failed the test, but results are closed to specification limits.He valve was dismantled and examined under microscope at appropriate magnification: tear and cuts marks were observed in the needle chamber.Root cause analysis - the root cause for underdrainage issue is due to a leak in the needle chamber.The root cause for the leak in the needle chamber is due to human misuse: silicone has a low cut and tear resistance.Do not use sharp instruments when handling the silicone valve or catheter; use shod forceps.Cuts or abrasions from sharp instruments may rupture or tear the silicone components.Do not fold or bend the valve during insertion.Incorrect insertion may cause rupture of the silicone housing.

• 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: 22283719
• Report Number: 3013886523-2025-00152
• Device Sequence Number: 8310029
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)280331(10)7225095
• 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): 10/24/2025

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: 7225095
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian