MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG MININAV®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	FV660T
Medical Device Problem Code	Reflux within Device (1522)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
According to the complainant a mininav valve 10 "part#: fv660t" was implanted on an unspecified date.Reportedly the valve was taken out of the patient because "the arrow was pointed distally.".
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of under-drainage / defect reflux, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in the horizontal position.The results show that the valve is not operating within the acceptable tolerance in the vertical position.Internal inspection: after dismantling of the valve, deposits were found inside.Result in advance, we would like to point out that the product sent in was not submerged in liquid at the time of delivery.The testing of dry valves is only of limited value.The product properties can be influenced by dry residues of cerebrospinal fluid or blood.Nevertheless, we have examined the valve.According to the results of the investigation, a reduced outflow was detected.The visible deposits led to the functional deviation.Deposits caused by substances naturally present in the patient's 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 organic material can affect the integrity of the valve.The examination of the return has been completed with the drafting of this report.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.

• Brand Name: MININAV®
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ,; GM 14469,
• MDR Report Key: 23573193
• Report Number: 2916714-2025-00075
• Device Sequence Number: 9885607
• Product Code: JXG
• UDI-Device Identifier: 04041906133085
• UDI-Public: (01)04041906133085(11)250512(17)300429(10)20082639
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/04/2025
• Report Date (Section F): 11/17/2025

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: FV660T
• Device Catalogue Number: FV660T
• Device Lot Number: 20082639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/05/2025
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2025
• 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: 11/17/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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: 3 MO
• Patient Sex: Female
• Patient Weight: 6 KG
• Date Report Sent to FDA: 11/17/2025