MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICRO CHPV UNITIZED

Model Number	82-3114
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id 823114) was implanted via v-p shunt on (b)(6) 2019 with unknown setting for the treatment of epilepsy.On june 25, 2019, the set pressure was changed to 50 mmh2o.In 2020, the physician tried to change the set pressure using neodymium, but could not change.It is unknown if the patient- experienced any signs and symptoms.Then it was tried to change the set pressure on (b)(6) 2022 using the neodymium however, the set pressure could not be change.Therefore, the valve was removed and replaced on the same day,.
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 823114) was returned for evaluation.Device history record (dhr) - product code 82-3114 with lot 3276903, showed 1 report when released to stock.The nr report issues had no link to this complaint.Failure analysis - the valve was visually inspected; biological debris was noted inside the valve.The position of the cam when valve was received was 50mmh2o.The valve was hydrated.The valve was leak tested and no leaks noted.The valve was reflux tested and failed.The valve was then pressure tested and failed.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, and on the base plate.The valve passed the test for programming and occlusion.No root cause could be determined for the programing issue, reported by the customer, as the technician could not confirm any programing issues with the valve at the time of investigation.The root cause for the reflux and pressure issues noted during the investigation is due to the biological debris found on the spring, on the spring pillar, on the ruby ball, on the seat of the ruby ball, and on the base plate.The possible root cause for the issue reported by the customer, could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation no programing issues was noted.
Event or Problem Description
N/a.

• Brand Name: MICRO CHPV UNITIZED
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14015394
• Report Number: 3013886523-2022-00128
• Device Sequence Number: 15021378
• Product Code: JXG
• UDI-Device Identifier: 10886704041498
• UDI-Public: (01)10886704041498(17)231031(10)3276903
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: 10/31/2023
• Device Model Number: 82-3114
• Device Catalogue Number: 823114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2018
• 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
• Patient Sex: Unknown