MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA2.0 15 AND SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX384T
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/20/2025
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
It was reported that a progav 2.0 shunt system (#fx384t) was implanted during a procedure.According to the complainant, the shunt system is clogged.The patient underwent a revision procedure.The complained product will be sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Additional information: d4 item information d6b expiration date d9 device returned to manufacturer date f9 approximate age of device.Visual inspection: during the investigation, no significant deformations or damage of the valve 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.The valves are tested in both the horizontal as well as the vertical positions.The results show that the progav 2.0 operates within the accepted tolerance in the horizontal position.The shuntassistant 2.0 does not operate within the specified tolerances in the vertical position.An accelerated outflow of shuntassistant 2.0 could be determined.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected and the braking force is within the given tolerances.Results: please note that a comprehensive examination of the progav 2.0 shunt system is not possible because we received no approval for the destructive examination despite several requests.According to the results of the investigation, we cannot determine functional deviations of the progav 2.0.The valve operated within all specifications.Furthermore, an accelerated outflow of the shuntassistant 2.0 was detected.Regarding similar complaints where we could examine the inside of 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 accelerated outflow is only possible by an examination we can exclude a defect at the time of release.The shunt system 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: PROGAV 2.0 WITH SA2.0 15 AND SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 23782976
• Report Number: 2916714-2025-00076
• Device Sequence Number: 17413620
• Product Code: JXG
• UDI-Device Identifier: 04041906502454
• UDI-Public: (01)04041906502454(17)280316(10)20064736
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/26/2026
• Report Date (Section F): 12/11/2025

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: FX384T
• Device Catalogue Number: FX384T
• Device Lot Number: 20064736
• 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: 11/18/2025
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2025
• 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: 12/11/2025
• Supplement Report FDA Received Date: 01/26/2026
• 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: 12/11/2025