MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number	823832
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	01/22/2025
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 haim valve (id 823832) was implanted on (b)(6) 2025.On (b)(6) 2025, the physician detected subcutaneous hydrops in the patient.Therefore, the valve was removed and replaced on (b)(6) 2025.Upon removal, it was discovered that the valve was broken.The patient is currently stable.
Additional Manufacturer Narrative
The haim valve (id (b)(6)) was not returned for evaluation, however a photo was provided: dhr - lot 7286596 conformed to the specifications when released to stock.Failure analysis - a photo was provided by the customer showing the cut/tear in the silicone housing.The complaint is confirmed.Root cause - no root cause could be determined as the device was not returned for investigation.The possible root cause for the issue reported by the customer, ¿could not be clearly determined but could be linked to a sharp or pointed object coming into contact with the device, as noted in the ifu silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE W SG
• 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: 21483103
• Report Number: 3013886523-2025-00044
• Device Sequence Number: 19832289
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)280731(10)7286596
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/07/2025

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: 823832
• Device Lot Number: 7286596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2023
• 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: 10 MO
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian