MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE W SG 823832; INTERNAL CSF DRAINAGE

Catalog Number	823832
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	01/19/2026
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.
Event or Problem Description
A facility reported that the patient was diagnosed with hydrocephalus and underwent ventriculoperitoneal (vp) shunt placement on (b)(6) 2024.Postoperatively, the shunt valve pressure was gradually adjusted.On (b)(6) 2025, a follow up ct scan showed no significant reduction in ventricular size, but confirmed patency of the peritoneal catheter.On (b)(6) 2025, repeated ct scan revealed persistent ventriculomegaly, prompting further reduction of shunt valve pressure.By (b)(6) 2025, no improvement was observed, suggesting shunt valve malfunction.On (b)(6) 2026, imaging confirmed recurrent ventriculomegaly, and the patient underwent shunt valve replacement with a new valve (id 823101).The pressure was set at 90 mmh2o.The patient currently exhibits mild improvement in mental status, though ventriculomegaly persists.A continued follow-up is advised.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823832) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history records (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint could be due to biological debris: as mentioned in the ifu "accumulation of biological matter (i.E.Blood, protein accumulations, tissue fragments, etc.) in the programming mechanism can cause inability of the device to be reprogrammed.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.
Event or Problem Description
Na.
Additional Manufacturer Narrative
The hakim valve (id (b)(6)) was returned for evaluation.Device history review: the product code 82-3832 with lot 7025220, conformed to the specifications when released to stock.Failure analysis: the position of the cam when the valve was received was at setting 30 mmh2o.The valve was visually inspected; the siphon guard was broken.Tear and cut marks were noted around the silicone housing and the siphon guard.The valve failed the programming test.The flush, leak, reflux, siphon guard tests could not be performed as the silicone housing at siphon guard area was torn.The pressure test could not be performed as the device did not program.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris were found on the ruby ball, on the seat of the ruby ball and motor.A visual check of the magnetization motors was carried out; the valve passed the test.Root cause analysis: no root cause could be clearly determined as the technician could not performed all the test in view of valve condition.The possible root cause for the issue could be due to biologicals debris as noted in ifu: accumulation of biological matter within the valve can: cause difficulties adjusting the valve setting with the tool kit and impair the anti-reflux function.Complications of implanted shunt systems include mechanical failure, shunt pathway obstruction, infection, foreign body (allergic) reaction to implants, and csf leakage along the implanted shunt pathway.Clinical signs such as headache, irritability, vomiting, drowsiness, or mental deterioration might be signs of a nonfunctioning shunt.The root cause for the siphon guard broken is due to a sharp or pointed object coming into contact with the valve in view of the cut marks on siphon guard and needle chamber.As noted in the surgical procedure precautions section in ifu, silicone has low cut/tear resistance.

• Brand Name: PROG VALVE INLINE W SG 823832
• 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: 24470321
• Report Number: 3013886523-2026-00040
• Device Sequence Number: 13345184
• Product Code: JXG
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Catalogue Number: 823832
• Device Lot Number: 7025220
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 04/08/2026; 06/11/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/24/2026; 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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: 20 YR
• Patient Sex: Female
• Patient Race: Asian