MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG MININAV VALVE 10; HYDROCEPHALUS MANAGEMENT

Model Number	FV660T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that a minivav valve 10 (#fv660t) was implanted.According to the complainant, the valve caused an underdrainage/blockage.The patient underwent a revision procedure.The complained product was not yet sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.
Event or Problem Description
It was reported that a minivav valve 10 (#fv660t) was implanted.According to the complainant, the valve caused an underdrainage / blockage.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.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformation or damage of the valve was determined.Permeability test: a permeability test has indicated that the valve has a blockage.Computer controlled test: due to the blockage, it was not possible to take a measurement on the computer test bench.Internal inspection: after dismantling of the valve, organic deposits were found in mininav.Result : according to the investigation results, a blockage was detected.The visible deposits have led to the functional impairment.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.We would like to point out, that testing dry products is of limited value.Dry residues of organic material can falsify the test results.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 VALVE 10
• 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: 21373906
• Report Number: 3004721439-2025-00045
• Device Sequence Number: 12911144
• Product Code: JXG
• UDI-Device Identifier: 04041906133085
• UDI-Public: 4041906133085
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/22/2025

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: 20073902
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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 Sex: Unknown