MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD MICRO CHPV UNITIZED

Catalog Number	823114
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2024
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) was implanted on (b)(6) 2023.It stopped draining, therefore, the valve was replaced on (b)(6) 2024.The patient is doing well.According to information provided, it is not known if there was an obstruction.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823114) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to biological debris and protein build up interfering with the device.But it was not possible to confirm and identify the root cause of this assumption as the product was not returned for investigation.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The valve received is a certas valve while the complaint concerns a chpv valve.Device history record (dhr) - product code 82-1745 with lot 7204533, conformed to specifications when released to stock.Failure analysis - the valve received is not the correct one.The valve received is a certas valve while the complaint concerns a chpv valve.Root cause analysis - no root cause could be determined because the valve received is not the correct one.The valve received is a certas valve while the complaint concerns a chpv valve.A possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the device.However, it was not possible to confirm and identify the root cause of this assumption as the good product was not returned for investigation.

• 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: 19838983
• Report Number: 3013886523-2024-00217
• Device Sequence Number: 15100376
• Product Code: JXG
• UDI-Device Identifier: 10381780519171
• UDI-Public: (01)10381780519171(17)280331(10)7204533
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 03/07/2025

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: 7204533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 02/19/2025
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/20/2024; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2023
• 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: 8 MO
• Patient Sex: Female