MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FX410T
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the investigation, discoloration on the outer housing of the progav2.0 was determined.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in the horizontal position.The results show that the valve operates not within the acceptable tolerance in the horizontal position.An accelerated outflow was determined.Adjustment test: the progav 2.0 was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function is operational.However, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valve, organic deposits were found in progav 2.0.Result: according to the investigation results, a non-adjustability and an accelerated outflow were detected.The visible deposits have led to the functional deviations.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.The examination of the return has been completed with the drafting of this report.We can exclude a defect at the time of release.The valve 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 to aesculap inc.That a m.Blue plus valve (part# fx804t) was implanted on an unspecified date.According to the complainant there was difficulty reprogramming both valves.The patient's device never had issues being reprogrammed as such the treating physicians wanted to closely monitor the patient's protein level and stated that they did not want to perform any additional medical interventions at that time or take any further actions.Reportedly on (b)(6) 2025, the patient was seen in the office with the sales representative present to assist with any re-programming, and it was on this day that the treating physicians decided to medically intervene.The adverse event is filed under (b)(4).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

• Brand Name: PROGAV 2.0 VALVE
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 21507176
• Report Number: 2916714-2025-00006
• Device Sequence Number: 7974213
• Product Code: JXG
• UDI-Device Identifier: 04041906136529
• UDI-Public: (01)04041906136529(11)231101(17)281026(10)20072031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/31/2025
• Report Date (Section F): 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: FX410T
• Device Catalogue Number: FX410T
• Device Lot Number: 20072031
• 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: 02/10/2025
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/31/2025
• 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 Age: 4 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/03/2025