MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV INLIN/SG INTEGRAL CON; CHPV WITH SG

Catalog Number	823842
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194); Ambulation or Postural Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
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 a hakim valve (id (b)(6)) was implanted in (b)(6) 2024.After some weeks of complaints and several pressure changes , the surgeon concluded that the valve was not working, therefore, 10 weeks after implantation, the valve was removed and replaced for a certas plus.The patient is doing good.
Additional Manufacturer Narrative
Additional health effect - clinical code1: e083804.Additional information provided: date of implantation? the patient was operated in (b)(6) 2024.Was the patient exposed to mri or other known magnetic fields? if so, what type of magnet? what was the strength (gauss) of the mri? no, the patient only did a 1,5 tesla mri in 15th of april, the day before the surgery.Was the setting of the valve confirmed after last programming or before the mri? if yes, was it checked using valve programming tools and/or x-ray? the valve was regulated to 110 mm and it was confirmed three times before the mri.The confirmation was performed four times with two different programing devices.Was the patient exposed to significant acceleration or deceleration such as a car accident or fall? there wasn't any accident or other issues with deceleration.No report.Did the patient experience any symptoms due to the pressure change? if yes, could you please describe them? yes, the patient had symptoms due to pressure change.She had dizziness, skull pressure and imbalance.She had to nausea and photophobia.Date of revision: the revision surgery was performed in (b)(6) 2024.Is the patient an elderly person, an adult, a child or a baby? the patient 53 years old woman, with no other illnesses.
Additional Manufacturer Narrative
The hakim valve was returned for evaluation: dhr - lot 5038018, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected: no defects noted.The valve failed the test for programming.The valve was leak tested; leaked from the damaged silicone housing.The valve passed the tests for occlusion, reflux, siphon guard, and pressure.The cam mechanism was gently moved.The valve was retested for programming, the valve failed the test, the cam mechanism did not move during the programming process.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was noted on the spring on the cam mechanism and on the base plate.The cam magnets were controlled: the magnets passed.Root cause - the root cause for the issue reported by the customer is probably due to programing issue noted during the investigation.The root cause for the programing issue noted during the investigation is due to biological debris and protein build found on the spring on the cam mechanism and on the base plate.

• Brand Name: CHPV INLIN/SG INTEGRAL CON
• Common Device Name: CHPV WITH SG
• 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: 19391944
• Report Number: 3013886523-2024-00154
• Device Sequence Number: 12701073
• Product Code: JXG
• UDI-Device Identifier: 10381780519836
• UDI-Public: (01)10381780519836(17)250930(10)5038018
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2024

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: 09/30/2025
• Device Catalogue Number: 823842
• Device Lot Number: 5038018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 05/28/2024; 06/18/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/16/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• 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: 53 YR
• Patient Sex: Female