MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV RT ANG RESERVOIR UNITIZED

Catalog Number	823148
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Headache (1880); Vomiting (2144)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported an 8-year-old female patient who experienced shunt occlusion, vomiting, headache during the use of hakim valve (id unknown) for unknown indication.Not reported: patient medical history, concurrent condition, family history, past medication, concomitant and co-suspect medications.On an unknown date, the patient underwent implantation of a codman hakim programmable valve at the age of 40 days via unknown route.On an unknown date, patient experienced shunt block and shunt failure and was removed on (b)(6) 2024, with external ventricular drainage (evd) insertion.She was doing good with complaint of vomiting, headache.The magnetic resonance imaging (mri) showed shunt failure and she had endoscopic third ventriculostomy (etv) but failed indicating shunt dependency.Later she underwent ¿pgm¿ shunt which was failed.At present she is on evn planning for revision of ¿pgm¿ shunt surgery.The outcome of the event was unknown and medical intervention is required.The action taken with hakim valve was unknown.This case was assessed as serious due to other medically important condition and hospitalization.This case was verified by a physician.The causality for the reported events is considered as not assessable due to limited therapy details of the suspect drug, onset date and outcome of the reported events, co-suspects, concomitant medication and relevant medical history.As per the company safety information, the reported events shunt occlusion, shunt malfunction, vomiting and headache are labeled.
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: d9, g3, g6, h2, h3, h6, h11.The hakim valve was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined, however, a possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the device.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 Manufacturer Narrative
Device history record (dhr) update - review of the history device records was not possible as the lot number is unknown.Product id updated: 823148: udi - (b)(4).
Event or Problem Description
N/a.

• Brand Name: CHPV RT ANG RESERVOIR UNITIZED
• Common Device Name: CHPV
• 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: 19838974
• Report Number: 3013886523-2024-00213
• Device Sequence Number: 6768758
• Product Code: JXG
• UDI-Device Identifier: 10381780519225
• UDI-Public: 10381780519225
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2025

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: 823148
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 03/04/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/20/2024; 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 8 YR
• Patient Sex: Female