MAUDE Adverse Event Report: Christoph Miethke GmbH & Co KG GAV 2.0 VALVE 5/30; HYDROCEPHALUS MANAGEMENT

Model Number	FX212T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a gav 2.0 (#fx212t) was implanted on (b)(6) 2026.According to the complainant, the valve caused an underdrainage.The patient underwent a revision procedure on (b)(6) 2026.The sample was returned for examination.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, no significant deformations or damage of the valve was determined.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled 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 gav 2.0 operates within the accepted tolerance in both positions.Internal inspection : after dismantling of the valve, organic deposits were found.Summary of the investigation results: according to the results of investigation, visible deposits were detected in the gav 2.0.The deposits had no effect upon the specifications at the time of the examination.The valve operated within all specifications.Organic material in the csf can temporarily influence the function and are known side effects in hydrocephalus therapy.

• Brand Name: GAV 2.0 VALVE 5/30
• 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: 50515559
• Report Number: 3004721439-2026-00227
• Device Sequence Number: 13142236
• Product Code: JXG
• UDI-Device Identifier: 04041906500023
• UDI-Public: (01)04041906500023(11)260120(17)310119(10)20087726
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 08/31/2026

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 Model Number: FX212T
• Device Catalogue Number: FX212T
• Device Lot Number: 20087726
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 MO
• Patient Sex: Male
• Patient Weight: 19 LB