MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV RT ANG RESERVOIR UNITIZED; INTERNAL CSF DRAINAGE

Catalog Number	823148
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	Cerebral Ventriculomegaly (2133); Confusion/ Disorientation (2553)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id 823148) was implanted on (b)(6) 2025, with initial pressure fixed at 120mmh2o.The physician tried to adjust the pressure periodically, however, they found mismatch against the set pressure.The patient experienced a decline in sensorium, and imaging showed ventricular dilatation despite the shunt tubing being in situ.The patient was admitted, the shunt adjusted to 40mmh2o, even though icp wasn't settled, and adjusted, the csf drainage wasn't flowing through shunt, therefore it was removed on (b)(6) 2026.
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 was not returned for evaluation; 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, however, the potential root cause for the reported issue could be due to biologicals debris.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.Additional information received: "on (b)(6) 2025, the patient was implanted with chpv shunt (codman hakim programmable valve) medical device.The lot/ batch number was 7525874 and expiry date were not reported.Catalog number: 823148.Initial pressure fixed at 120mmh2o"."on (b)(6) 2026, the later thrice the time physician tried to adjust the pressure periodically, every time of adjustment but found mismatch against the set pressure, due to increased icp pressure (intracranial pressure increased) and patient got admitted in hospital, then shunt adjusted into 40mmh2o, even though icp wasn't settled, and done a procedure, and found csf drainage wasn't happening through shunt (cerebrospinal fluid retention), now shunt got removed from the patient on (b)(6) 2026.Neurosurgeons claimed it may be on shunt malfunction, due to product problem, patient had symptom of drop in sensorium, on imaging dilatation of ventricle seen despite of shunt tube insitu and still the symptom continued.Retrieved shunt was there with the surgeon side, surgeon requesting replacement.Device was not yet replaced, asking to replace as immediate"."outcome of the event shunt malfunction was unknown, intracranial pressure increased was not recovered/ongoing and cerebrospinal fluid retention, depressed level of consciousness was unknown".Pertinent lab data was not reported.Reporter's remarks: "this is a serious spontaneous case regarding a 72-year-old elderly not hispanic/ latino asian male patient, who had shunt malfunction, intracranial pressure increased, cerebrospinal fluid retention and sensorium decreased during the use of chpv shunt (codman hakim programmable valve) medical device for an unreported indication.The company safety manual lists shunt malfunction, and cerebrospinal fluid retention as potential adverse events.Cerebrospinal fluid retention may also have resulted from shunt malfunction.The events intracranial pressure increased, and sensorium decreased are unlabeled.Therefore, a causal relationship between adverse events shunt malfunction, intracranial pressure increased and cerebrospinal fluid retention and sensorium decreased, in relation to the device, cannot be ruled out".

• Brand Name: CHPV RT ANG RESERVOIR UNITIZED
• Common Device Name: INTERNAL CSF DRAINAGE
• 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: 24711782
• Report Number: 3013886523-2026-00062
• Device Sequence Number: 5989200
• Product Code: JXG
• UDI-Device Identifier: 10381780534563
• UDI-Public: (01)10381780534563(17)300228(10)7525874
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 823148
• Device Lot Number: 7525874
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian