MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W/SA2.0 25 & DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX649T
Medical Device Problem Codes	Obstruction of Flow (2423); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 was implanted during on (b)(6) 2020.According to the patient, the valve had adjustment difficulties.A revision procedure was carried out on (b)(6) 2025.No patient complications were reported as a result of the revision procedure.The complained product was not yet sent to the manufacturer for investigation.
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx649t) was implanted during on (b)(6) 2020.According to the patient, the shunt system caused an underdrainage and had adjustment difficulties.A revision procedure was carried out on (b)(6) 2025.No patient complications were reported as a result of the revision procedure.The complained product was sent to the manufacturer for investigation.
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the progav 2.0 were determined.Permeability test: a permeability test has shown that all components are 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 valves are tested in both the horizontal as well as the vertical positions.The results show that the progav 2.0 operates within the accepted tolerance in the horizontal position.The shuntassistant 2.0 does not operate within the specified tolerances in the vertical position.An accelerated outflow of shuntassistant 2.0 could be determined.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 operates as expected and the braking force is within the given tolerances.Internal inspection: after dismantling of the valves, no deposits were found in both valves.Results: based on our investigation results, we can determine an accelerated outflow at the shuntassistant.Furthermore, we cannot determine any functional deviations or other abnormalities at the progav 2.0.The valve works within the specification.Since the product was placed in liquid just before it was returned to us and was therefore dry from explantation (b)(6) 2025) until it was returned to us (b)(6) 2025), testing the products is only of limited use.Dry residues of organic material can falsify the investigation results.At the time of the examination, it is not possible for us to determine how the functional impairment occurred.Organic material in the patient's own csf may have temporarily affected the function and is a known side effect of hydrocephalus therapy.Not every deposit in a shunt system, depending on its location, quantity and consistency, leads to a deterioration of the properties.The examination of the return shipment is completed with the preparation of this report.We can exclude a defect at the time of release.The shunt system 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 W/SA2.0 25 & DISTAL CATHETER
• 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: 21662338
• Report Number: 3004721439-2025-00079
• Device Sequence Number: 18250463
• Product Code: JXG
• UDI-Device Identifier: 04041906502072
• UDI-Public: 4041906502072
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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 Expiration Date: 10/29/2024
• Device Model Number: FX649T
• Device Catalogue Number: FX649T
• Device Lot Number: 20044532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2019
• 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 Age: 51 YR
• Patient Sex: Female
• Patient Weight: 77 KG