MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SYST VALVE NP M LINE ASD; PRECISION

Catalog Number	823813
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
2 of 2 reports.Other mfg report number: 3013886523-2025-00063.A facility reported a hakim valve was implanted on (b)(6) 2025.Cerebrospinal fluid (csf) was not flowing, therefore, it was removed and replaced an (b)(6) 2025.A second valve was implanted on (b)(6) 2025, and the same failure was found, therefore it was explanted on (b)(6) 2024.
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
Updated fields: d1, d2a, d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve was returned for evaluation: - dhr - lot 7480849, sn (b)(6), conformed to the specifications when released to stock.- failure analysis - the valve was visually inspected; needle hole was observed during irrigation.The valve was flushed per wi-msp204 rev.15, the valve passed the test.No defects were noted.The complaint was unconfirmed.- root cause - at the time of investigation no function issues were noted.The root cause for the issue reported by the customer could be due to after steam sterilization the ruby ball sticks to the ruby seat and potential effects of failure include ¿excessive pressure required to flush the valve pre-procedure ("valve popping")¿as noted in the ifu.And/or 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Root cause update: the possible root cause for the issue reported by the customer can caused by an excessive flow rate (>0.75 ml/min) activates the siphonguard device and creates the impression that the valve is distally occluded.In reality, flow is being diverted to the high resistance secondary pathway, as noted in the flushing procedure section in the ifu.And/or 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 as mentionned in the ifu "accumulation of biological matter (i.E.Blood, protein accumulations, tissue fragments, etc.) in the programming mechanism can cause inability of the device to be reprogrammed.
Event or Problem Description
N/a.

• Brand Name: SYST VALVE NP M LINE ASD
• Common Device Name: PRECISION
• 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: 21773361
• Report Number: 3013886523-2025-00064
• Device Sequence Number: 15503844
• Product Code: JXG
• UDI-Device Identifier: 10381780534907
• UDI-Public: (01)10381780534907(17)291031(10)7480849
• 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,Followup
• Report Date (Section B): 01/02/2026

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: 823813
• Device Lot Number: 7480849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 12/08/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 06/24/2025; 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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 Sex: Unknown