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

Model Number	FX490T
Medical Device Problem Codes	Obstruction of Flow (2423); Calibration Problem (2890)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the event description: urgent shunt revision on a 11 month old male.The valve seemed to have flow following explant but required many outpatient adjustments.The clinical team is suspecting occlusion or faulty mechanism and requesting analysis post explant to confirm.
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.

• 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: 24715616
• Report Number: 2916714-2026-00010
• Device Sequence Number: 5677264
• Product Code: JXG
• UDI-Device Identifier: 04041906137786
• UDI-Public: (01)04041906137786(11)250210(17)300206(10)20080526
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 04/14/2026
• Report Date (Section F): 03/27/2026

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: FX490T
• Device Catalogue Number: FX490T
• Device Lot Number: 20080526
• 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: 03/12/2026
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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: 11 MO
• Patient Sex: Male
• Date Report Sent to FDA: 03/27/2026