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	Hydrocephalus (3272)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a gav 2.0 (#fx215t) was implanted during a procedure.According to the complainant, the valve caused drainage problem.Deemed pressure setting was too high for patient the patient underwent a revision procedure.The complained product will be sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.Same patient as medwatch#3004721439-2025-00333.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a gav 2.0 (#fx215t) was implanted during a procedure.According to the complainant, the valve caused drainage problem.Deemed pressure setting was too high for patient.The patient underwent a revision procedure.The complained product was sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.Same patient as medwatch# 3004721439-2025-00333.
Additional Manufacturer Narrative
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.

• 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
• 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: 23463426
• Report Number: 3004721439-2025-00334
• Device Sequence Number: 9084932
• 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
• PMA/510(K) Number: K190174
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 62 KG