MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX431T
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 (#fx431t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the shunt is not working properly.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 result is still pending due to the lack of approval for the examination.
Additional Manufacturer Narrative
Manufacturing site evaluation: the record of the production did not reveal any unusual findings.The shunt system met all specifications before shipment.The approval for examination is not available.Due to this fact a meaningful examination is not possible at the time of this report.Should relevant additional information become available, a supplemental medwatch report will be submitted.
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 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 valve operates within the permissible tolerance in its 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 wählen sie ein element aus.Internal inspection: after dismantling of the valve, no deposits were found in.Results: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.How the abovementioned functional impairment occurred is not clear to us at the time of 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.
Event or Problem Description
It was reported that a progav 2.0 (#fx431t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the shunt is not working properly.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.

• Brand Name: PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR
• 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: 21732594
• Report Number: 3004721439-2025-00068
• Device Sequence Number: 4197108
• Product Code: JXG
• UDI-Device Identifier: 04041906137298
• UDI-Public: 4041906137298
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• 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): 04/02/2025

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: FX431T
• Device Catalogue Number: FX431T
• Device Lot Number: 20070464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2025
• Supplement Date Received by Manufacturer: 03/08/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2023
• 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: 25 YR
• Patient Sex: Male
• Patient Weight: 90 KG