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	Ambulation or Postural Difficulties (2544)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve was implanted in 2017 to treat hydrocephalus.In (b)(6)2023 patient presented with walking difficulties, no sign of intracranial hypertension.Mri show sign of over-drainage.X ray show that main body part of valve could not be set up.A revision surgery was needed to replace the main body of the valve.Patient recovering.
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
Hakim valve was returned for evaluation: dhr - lot 104154, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; the stator and x ray dot were dislodged.The valve was dismantled and was examined under microscope at appropriate magnification: corrosion on stator and x ray dot, and biological debris on cam mechanism was also noted.The cam magnets were controlled per process: the magnets failed.Root cause - the root cause for the dislodged stator and x ray dot is due to corrosion, the corrosion could not be clearly determined.Galvanic corrosion could not be established as a direct root cause for the valves investigated, however it was found to be a contributing factor with trauma to the valve.Corrosion, when it arises, only arises after long term exposure to csf.The valve has been implanted for at least 6 years.The root cause for the abnormal polarization noted during the investigation, was probably caused by an exposition of a too strong magnetic field, as noted in the ifu, ¿any magnet may experience a degradation of magnetic field strength as a consequence of exposure to the significantly stronger magnet field induced in a mri procedure.

• Brand Name: MICRO CHPV UNITIZED
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17350243
• Report Number: 3013886523-2023-00227
• Device Sequence Number: 6016665
• Product Code: JXG
• UDI-Device Identifier: 10886704041498
• UDI-Public: (01)10886704041498(17)210930(10)104154
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 823114
• Device Lot Number: 104154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2016
• 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
• Patient Age: 72 YR
• Patient Sex: Female