MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 VALVE 10/30; HYDROCEPHALUS MANAGEMENT

Model Number	FX215T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant the surgeon had previously implanted valve in patient and shunt was not draining at a rate surgeon felt was appropriate.Reportedly the pressure setting was too high for patient.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Additional information: d1, d2a, d4 device information updated.Investigation: visual inspection: during the investigation, no significant deformation or damage of the valve was determined.Permeability test: a permeability test has shown that the valve is permeable.Computer control test: to investigate the claim of under-drainage, 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.The results show that the valve operates within the accepted tolerance in the horizontal but not in the vertical position.A tendency to an accelerated outflow of gav 2.0 was measured.Internal inspection: after dismantling, organic deposits were found in gav 2.0.Results: based on our investigation results, we can determine an accelerated outflow at the valve.The determined deposits can be named as the cause for the functional deviation.Organic material in the cerebrospinal fluid can influence the function temporarily and are known inherent side effects in hydrocephalus therapy.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

• Brand Name: GAV 2.0 VALVE 10/30
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ,; GM 14469,
• MDR Report Key: 23486109
• Report Number: 2916714-2025-00070
• Device Sequence Number: 21464338
• Product Code: JXG
• UDI-Device Identifier: 04041906500054
• UDI-Public: (01)04041906500054(11)240607(17)290605(10)20075762
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025
• Report Date (Section F): 11/06/2025

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 Model Number: FX215T
• Device Catalogue Number: FX215T
• Device Lot Number: 20075762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male
• Date Report Sent to FDA: 11/06/2025