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

Model Number	FV660T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a mininav valve 10 (part# fv660t) was implanted on an unspecified date.According to the complainant there was a shunt malfunction resulting in a shunt revision.Upon testing of the mini nav (flush with nacl) the fluid did not pass through mini nav.The adverse event is filed under aic reference: (b)(4).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.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.

• 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: 21397811
• Report Number: 2916714-2025-00004
• Device Sequence Number: 18110770
• Product Code: JXG
• UDI-Device Identifier: 04041906133085
• UDI-Public: (01)04041906133085(11)240222(17)290221(10)20073902
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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): 04/22/2025
• Report Date (Section F): 02/18/2025

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
• Date Returned to Manufacturer: 02/13/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2025
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/22/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 02/18/2025