MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM PED.WITH PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX438T
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 (#fx438t) was implanted together with an shuntassistant (fv413-t) during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system had adjustment difficulties.The patient underwent a revision procedure on (b)(6) 2025.The complained products were sent to the manufacturer for investigation.No patient complications were reported as a result of the revision procedure.Same incident as medwatch #3004721439-2025-00220.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, bloody tissue residues/deposits on the device was determined.No significant deformations or damage.Permeability test: a permeability test has indicated that the valve is clogged.Computer controlled test: because the valve is not permeable, a computer control test is not applicable.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.Result: according to the investigation results, an occlusion and a non-adjustability oft he progav 2.0 was determined.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 reservoir showed some bloody tissue residues outside, but no functional defects.

• Brand Name: PROGAV 2.0 SYSTEM PED.WITH PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 22698255
• Report Number: 3004721439-2025-00219
• Device Sequence Number: 8986492
• Product Code: JXG
• UDI-Device Identifier: 04041906137434
• UDI-Public: 4041906137434
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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: FX438T
• Device Catalogue Number: FX438T
• Device Lot Number: 20058360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male