MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 VALVE 10/25; HYDROCEPHALUS MANAGEMENT

Model Number	FX214T
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a gav 2.0 (#fx214t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the shunt system caused an underdrainage.The patient underwent a revision procedure on (b)(6) 2024.No patient complications were reported as a result of the revision procedure.The complainant device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the valves were determined.Permeability test: a permeability test has shown that the valve has a blockage.Computer controlled test: to investigate the claim of blockage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.Because the valve is not permeable, a computer controlled test is not possible.Internal inspection: after dismantling of the valve, deposits were found in gav 2.0.Results: based on our investigation results, we can determine a clogging of the gav 2.0.The visible deposits in the valve have led to the functional impairment.Deposits caused by substances naturally present in the patient's body, such as organic matter, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve.The examination of the return has been completed with the drafting of this report.No further regulatory actions are required from our point of view.

• Brand Name: GAV 2.0 VALVE 10/25
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 20546222
• Report Number: 3004721439-2024-00327
• Device Sequence Number: 12627530
• Product Code: JXG
• UDI-Device Identifier: 04041906500047
• UDI-Public: 4041906500047
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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 Model Number: FX214T
• Device Catalogue Number: FX214T
• Device Lot Number: 20074529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 MO
• Patient Sex: Female
• Patient Weight: 5 KG