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

Catalog Number	823832
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id 823162) was implanted via ventriculoperitoneal shunt on january 10, 2024 with a set pressure of 70mmh2o.It was confirmed that the cerebrospinal fluid was not flowing due to obstruction; therefore, the valve was removed and replaced on january 10, 2024 with a set pressure of 20mmh20.According to information provided, it is unknown if the patient experienced any signs and symptoms due to obstruction.
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
Additional information received: the product was explanted on (b)(6) 2024.The certas valve (id 828801) with unknown lot number was implanted.Condition of the patient: the ventricles became smaller.She was confined to bed before surgery, and she still is.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve (id 823832) was returned for evaluation.Failure analysis - the valve was visually inspected; a needle hole in the needle chamber was noted.The position of the cam when valve was received was 30mmh2o.The valve was hydrated.The valve passed the test for programming, occlusion, leak, reflux, siphon guard and pressure.Root cause analysis - no root cause could be determined for the failure issue reported by the customer as the technician could not confirm any problems with the valve at the time of investigation.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.As noted in the complaint report, no occlusions were found with the device at the time of investigation.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18584255
• Report Number: 3013886523-2024-00006
• Device Sequence Number: 8517818
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)250228(10)4560706
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/15/2024

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: 02/28/2025
• Device Catalogue Number: 823832
• Device Lot Number: 4560706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 02/05/2024; 03/08/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/21/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2020
• 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: 54 YR
• Patient Sex: Female