MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 SYS W/PED.CONTROL RESERV.5/25; HYDROCEPHALUS MANAGEMENT

Model Number	FX153T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
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 all components are 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.He 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 the vertical but not in the horizontal position.A slowed outflow of gav 2.0 could be determined.Internal inspection: after dismantling of the components, deposits were found inside.Results: based on our investigation results, we can determine a slower flow rate at the gav 2.0 in the horizontal position.The deposits visible in the valve are the cause of the change in flow rate.Deposits caused by natural substances in the body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of proteins can impair the integrity of the valve.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a gav 2.0 shunt system (#fx153t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the shunt system showed an under-drainage.The patient underwent a revision procedure performed on (b)(6) 2024.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 6 months; weight: 4.9 kgs; height: 57 cm; gender: female.

• Brand Name: GAV 2.0 SYS W/PED.CONTROL RESERV.5/25
• 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: 20320759
• Report Number: 3004721439-2024-00292
• Device Sequence Number: 15399417
• Product Code: JXG
• UDI-Device Identifier: 04041906142926
• UDI-Public: 4041906142926
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/27/2024

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: FX153T
• Device Catalogue Number: FX153T
• Device Lot Number: 20062058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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: 6 MO
• Patient Sex: Female
• Patient Weight: 5 KG