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

Catalog Number	823832
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Fever (1858); Confusion/ Disorientation (2553); Hydrocephalus (3272)
Date of Event	04/08/2025
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.Additional codes for health effect - clinical code 1: e0505, e0103.
Event or Problem Description
This is 1 of 2 reports linked to mfg report numbers: 3013886523-2025-00090.A facility reported a hakim valve (id: 823832) and bactiseal catheter (id: 823072) was implanted via ventriculoperitoneal (vp) shunt operation on (b)(6) 2025.The postoperative condition is good.The patient was diagnosed with secondary hydrocephalus, history of brain tumor resection and prosthetic eye.Computed tomography (ct) reexamination on (b)(6) revealed hydrocephalus: a small amount of blood may be accumulated in the knee of the corpus callosum.On (b)(6), the patient developed low fever, and reexamination ct revealed a small amount of hematosis in the knee of the corpus callosum.On (b)(6), the patient had small strides and slow movement, and then the shunt pressure was adjusted from 160mm water column to 140mm water column.In the evening, the patient developed confusion of consciousness, and reexamination ct showed delayed bleeding at the right frontal puncture site, which was larger than before, peripheral edema, pressure on the frontal corner of the right lateral ventricle, and a thin subdural hematoma in the right frontotemporal area, with the midline structure shifting slightly to the left.Ct reexamination on (b)(6), showed no expansion of intracranial hematoma, aggravation of cerebral edema, further increase of intracranial pressure and hydrocephalus.On (b)(6), reexamination ct showed reduced hydrocephalus, hematoma in the ventricle system, hematoma in the knee of the right frontal lobe and corpus callosum, and subdural hematoma in the right frontal parietal and temporal area, with little change compared with before, and inflammation in the lungs on both sides.On (b)(6), the physician would like to extract cerebrospinal fluid from the needle chamber, no fluid was extracted, and normal saline flushing was smooth.On (b)(6), ct showed that the liquefaction of hematoma was reduced compared with the previous absorption, and hydrocephalus was aggravated.The re-examination ct on (b)(6) showed little change compared with that on (b)(6), and the pulmonary infection was more serious, so it was recommended to be transferred to the intensive care unit for treatment and transferred to the nicu on (b)(6).The physician suspected that the valve was occluded however, the product is still in use in patient.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id (b)(6)) was not returned for evaluation as the product was implanted therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• 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: 21944068
• Report Number: 3013886523-2025-00089
• Device Sequence Number: 8799799
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)281031(10)7302943
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 09/05/2025

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: 7302943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2023
• 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: 42 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian