MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 25 A.CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FX603T
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the valves, but no significant deformations or damage were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the valves, 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 was 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.Internal inspection: after dismantling of the valves, deposits were found.Results: based on the investigation results, no functional deviations or other abnormalities were detected in the progav 2.0.The valve is operating within specifications.Furthermore, computer-controlled testing of the shuntassistant 2.0 revealed a tendency toward accelerated outflow.The deposits visible inside the valve may have caused the change in flow rate.It should be noted here that when valves are opened, it is possible to view a large part of the interior.Nevertheless, there are areas that cannot be examined visually.Organic deposits may be present in these areas, which could impair function.Finally, visible deposits inside, as well as cuts in the membrane of the control reservoir, were observed.The deposits and cuts did not affect the technical properties at the time of the examination.Deposits caused by natural substances found 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 organic deposits can compromise the integrity of the valve.A defect at the time of release can be excluded.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.
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx603t) was implanted on (b)(6) 2025.The patient underwent a revision procedure on (b)(6) 2026.No reason for the explantation was given.No patient complications were reported as a result of the revision procedure.

• Brand Name: PROGAV 2.0 SYS SA2.0 25 A.CONTROL RES.
• 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: 25200180
• Report Number: 3004721439-2026-00138
• Device Sequence Number: 8889938
• Product Code: JXG
• UDI-Device Identifier: 04041906503239
• UDI-Public: (01)04041906503239(11)250110(17)300102(10)20079770
• 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: 2025
• Device Explanted Year: 2026
• 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): 05/18/2026

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: FX603T
• Device Catalogue Number: FX603T
• Device Lot Number: 20079770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• 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