MAUDE Adverse Event Report: Christoph Miethke GmbH & Co KG PROGAV 2.0 VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FX410T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 valve (#fx410t) was implanted on (b)(6) 2024.According to the complainant, the valve had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2026.The sample will be returned for examination.This report is filed under aic reference (b)(4).

• 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: 50379774
• Report Number: 50379774
• Device Sequence Number: 14868576
• Product Code: JXG
• UDI-Device Identifier: 04041906136529
• UDI-Public: (01)04041906136529(11)240506(17)290502(10)20075133
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026
• Report Date (Section F): 09/01/2026

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: 20075133
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/07/2026
• Device Age: 25 MO
• Event Location: Home
• Date Report to Manufacturer: 08/07/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Supplement Report FDA Received Date: 09/01/2026
• 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: 3 YR
• Patient Sex: Female
• Patient Weight: 39 LB
• Date Report Sent to FDA: 08/21/2026