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

Catalog Number	823164
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id 823164) was implanted via ventriculoperitoneal (vp) shunt due to secondary normal pressure hydrocephalus (snph) on (b)(6) 2019 with setting of 30mmh2o.The pressure setting could not be changed, therefore, the valve was removed and replaced on (b)(6) 2024.Based on the information provided it is unknown if the patient experienced any signs and symptoms.
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 (id (b)(6)) was returned for evaluation.Device history record (dhr) - the product code 823164 with lot 3276907 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 70 mmh2o.The valve was visually inspected; cut marks were noted on the housing.The valve was leak tested and failed the test due to leak from cut.The valve passed the test for programming, occlusion, reflux and pressure.Root cause analysis - the issue reported by the customer could be due to biological debris and protein build up interfering with the valve, at the time of investigation no programming issue was noted.The root cause for the ¿cut mark¿ is due to a sharp or pointed object coming into contact with the valve or atypical handling, as noted in the surgical procedure precautions section in ifu, silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE
• 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: 20080588
• Report Number: 3013886523-2024-00253
• Device Sequence Number: 15366725
• Product Code: JXG
• UDI-Device Identifier: 10886704041566
• UDI-Public: (01)10886704041566(17)231031(10)3276907
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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 Expiration Date: 10/31/2023
• Device Catalogue Number: 823164
• Device Lot Number: 3276907
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2018
• 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 Sex: Female