MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 VALVE 5/30; HYDROCEPHALUS MANAGEMENT

Model Number	FX212T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: the record of the production did not reveal any unusual findings.The shunt system met all specifications before shipment.The product is still in transit to the manufacturer.Due to this fact a meaningful examination is not possible at the time of this report.Should relevant additional information become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that an gav 2.0 shuntsystem (#fx212t) was to be implanted during a procedure performed on (b)(6) 2025.According to the complainant, the shunt system caused problems in the preoperative testing and wasn't used.No patient involvement or harm wsa reported.The complained device was not yet returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Manufacturing site evaluation: an investigation was not possible, because no product was return for investigation.Based on the product documentation, we can exclude a defect at the time of delivery of the gav 2.0, our traceability indicates that the valve was in perfect condition.Regarding similar complaints where we could examine the products, we could determine that the most frequent cause for a deterioration in the function of the product are deposits caused by natural substances in the cerebrospinal fluid, e.G.Protein, blood or tissue particles.These 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 if aggregated in the valve.A final clarification of the cause what has led to malfunction is only possible by an examination.Actions: no further actions are required as a result of the complaint.
Event or Problem Description
No device was returned to the manufacturer for evaluation.

• 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: 21873651
• Report Number: 3004721439-2025-00117
• Device Sequence Number: 8742329
• Product Code: JXG
• UDI-Device Identifier: 04041906500023
• UDI-Public: 4041906500023
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX212T
• Device Catalogue Number: FX212T
• Device Lot Number: 20070027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2023
• 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; Other
• Patient Sex: Unknown