MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	FX410T
Medical Device Problem Codes	Defective Component (2292); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	12/18/2025
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
It was reported to aesculap inc.That a progav 2 (part # unknown) was implanted on an unspecified date.According to the complainant, the device was explanted on (b))6) 2025 for an unspecified reason.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
The adverse event is filed under aic reference xc 100041269 cc 400742164.Additional information: d1 brand name.D4 item information.D9 device returned to manufacturer 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).Additional information: a2 patient age a3a patient gender b7 relevant history d6a and d6b implant and explant dates.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 the claim of under-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 within the accepted tolerances in the horizontal position.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 fully operational and the braking force is within the given tolerances.Internal inspection after dismantling of the valve, deposits were found.Result based on our investigation results, we can determine visible deposits in the pediatric burrhole reservoir.The deposits had no effect upon the specifications at the time of the examination.The reservoir operated within all specifications.Furthermore, a non-adjustability of the progav 2.0 was detected.The visible deposits led to the functional deviation.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.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.Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

• Brand Name: PROGAV 2.0®
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ,; GM 14469,
• MDR Report Key: 24007377
• Report Number: 2916714-2025-00077
• Device Sequence Number: 4810208
• Product Code: JXG
• UDI-Device Identifier: 04041906136529
• UDI-Public: (01)04041906136529(11)220617(17)270616(10)20059858
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026
• Report Date (Section F): 01/08/2026

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: FX410T
• Device Catalogue Number: FX410T
• Device Lot Number: 20059858
• 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: 12/22/2025
• Device Age: 43 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2025
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/23/2026; 01/30/2026
• 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: 66 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/08/2026