MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICRO CHPV UNITIZED

Catalog Number	823114
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2024
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 physician reported a hakim valve (id 823114) implanted on (b)(6) 2024 stopped draining.Therefore the valve was explanted and replaced on (b)(6) 2024.The patient is stable.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823114) was returned for evaluation.Device history record (dhr) - the product code 82-3114 with lot 7250352, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 40 mmh2o.The valve was visually inspected; the valve was inclined inside of the silicon casing.The valve failed the test for programming, occlusion, and reflux.The valve was leak tested and passed.The pressure test could not be performed as the device could not be programmed.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification; biological debris was found on the ruby ball, motor and on the seat of the ruby ball.Root cause analysis - the root cause for the programming and occlusion issues are due to biological debris and protein build up interfering with the valve.The possible root cause for the valve returned to the inside of the silicon is due to a too great pressure at the moment of the injection of liquid (from the biological debris), which inflated the silicon, and the valve turned.

• Brand Name: MICRO CHPV 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: 20786809
• Report Number: 3013886523-2024-00375
• Device Sequence Number: 6989584
• Product Code: JXG
• UDI-Device Identifier: 10381780519171
• UDI-Public: (01)10381780519171(17)280430(10)7250352
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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: 823114
• Device Lot Number: 7250352
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2023
• 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: 84 YR
• Patient Sex: Female