MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE CLYNDRICAL W PRECHA; CHPV

Catalog Number	823110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Headache (1880)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician assistant reported a hakim valve (id 823111) was implanted on (b)(6) 2017.On (b)(6) 2024, the patient visited a physician, complaining of headaches.The patient fell down the stairs prior to the shunt issue, but it was unclear whether he hit his head.An x-ray shunt, series and computed tomography (ct) scan were ordered to assess the condition of the shunt.Based on the scans, it was found that the hakim valve was broken.Its spiral staircase was no longer attached to the valve mechanism and was floating in the reservoir of the valve.The shunt lost tension on the spring that regulates the flow of cerebrospinal fluid (csf).Therefore, the valve was removed and replaced on (b)(6) 2024.
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
Updated fields: d1, d2a, d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823111) was returned for evaluation.Device history record (dhr) - the product code 82-3110 with lot crfb51, sn: (b)(6) conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; the mechanism valve and the stator were dislodged.It was not possible to test the valve as the stator was dislodged.The valve was dismantled and was examined under microscope at appropriate magnification: bump marks were noted in the valve casing, and corrosion was noted on the stator.Root cause analysis - the root cause for the dislodged stator noted during the investigation is due to the valve receiving a hard knock.The root cause for the bump marks in the valve casing noted during the investigation and the damaged cam mechanism is due to the valve receiving a hard knock.The root cause for the corrosion noted on the stator; the corrosion could not be clearly determined.

• Brand Name: PROG VALVE CLYNDRICAL W PRECHA
• 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: 21432800
• Report Number: 3013886523-2025-00039
• Device Sequence Number: 20010612
• Product Code: JXG
• UDI-Device Identifier: 10886704041450
• UDI-Public: (01)10886704041450(17)190430
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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 Expiration Date: 04/30/2019
• Device Catalogue Number: 823110
• Device Lot Number: CRFB51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2014
• 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: 7 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White