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

Model Number	FX467T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/25/2025
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
According to the event description the valve is not clicking or able to be reprogrammed.Reportedly the valve was adjusted to setting that the patient needed before implanting it.The valve worked fine when it was in the packaging but now that it is implanted in the patient it won't click and therefore, unable to be reprogrammed.Reportedly the patient will undergo a revision procedure but has yet to be scheduled.Additional information has been requested but not yet provided.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Correction: f6, awareness date.Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Visual inspection: during the investigation, no significant deformations or damage of the valves was determined.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate further, 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 is not operating within the acceptable tolerance in the horizontal position.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 is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valve and the control reservoir, no deposits were found.Result: based on our investigation results, we cannot determine functional deviations or other abnormalities in the progav 2.0 and the control reservoir.The components operated within all specifications.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.

• Brand Name: PROGAV 2.0 WITH CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ,; GM 14469,
• MDR Report Key: 22382286
• Report Number: 2916714-2025-00055
• Device Sequence Number: 8411298
• Product Code: JXG
• UDI-Device Identifier: 04041906137083
• UDI-Public: (01)04041906137083(11)240514(17)290512(10)20075257
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/20/2026
• Report Date (Section F): 07/02/2025

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: FX467T
• Device Catalogue Number: FX467T
• Device Lot Number: 20075257
• 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: 06/20/2025
• Device Age: 1 YR
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/08/2025; 08/22/2025; 02/20/2026
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Date Report Sent to FDA: 07/02/2025