MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 20 & PED.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX596T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information/investigation results became available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shunt system (#f x596t) was implanted in (b)(6) 2023.According to the complainant, the shunt system had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2025.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 deformations or damage of the valve were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the shuntsystem, 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 valves operate within the permissible tolerance in their respective relevant positions.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 in both valves.Results: based on our investigation results, we can determine visible deposits in both valves.The deposits had no effect upon the specifications at the time of the examination.The shuntsystem operated within all specifications.Organic material in the csf can temporarily influence the function and are known side effects in hydrocephalus therapy.The examination of the return has been completed with the drafting of this report.
Event or Problem Description
It was reported that a progav 2.0 shunt system (#: fx596t) was implanted on (b)(6) 2023.According to the complainant, the shunt system had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2025.The complained product was sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.The release for investigation from the clinic was submitted and the sample was investigated.

• Brand Name: PROGAV 2.0 SYS SA2.0 20 & PED.PRECHAMBER
• 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: 21344860
• Report Number: 3004721439-2025-00043
• Device Sequence Number: 7958366
• Product Code: JXG
• UDI-Device Identifier: 04041906503536
• UDI-Public: 4041906503536
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 03/03/2025

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: FX596T
• Device Catalogue Number: FX596T
• Device Lot Number: 20064184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• 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: 01/27/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 100 KG