MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 25 & CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FX603T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the shuntassistant 2.0 and the reservoir were determined, while the progav 2.0 was sent in already opened, the lid was not included in the delivery.Permeability test: a permeability test has shown that the shuntassistant 2.0 and the reservoir are permeable.The progav 2.0 could not be tested.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 shuntassistant 2.0 does not operate within the accepted tolerance in the vertikal position.An accelerated outflow of shuntassistant 2.0 could be determined.The progav 2.0 could not be tested.Adjustment test: the progav 2.0 could not be tested.Braking force and brake function test: the progav 2.0 could not be tested.Internal inspection: after dismantling of the valves, deposits were found in both valves.To make the deposits in the shunt system more visible, they were colored using a staining solution.Results: based on our test results, we can determine an accelerated outflow on the shuntassistant 2.0.The deposits visible in the valve may have led to the change in the flow rate.No meaningful assessment can be made for the progav 2.0, as the valve was already open and the opening pressure on delivery, adjustability test, braking function, braking force, measurement on the computer test bench and permeability could not be tested.Deposits were found in the already opened valve, which could be responsible for the malfunctions complained about.Deposits caused by natural substances in the 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 proteins can impair the integrity of the valve.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.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#: fx603t) was implanted during a procedure performed on (b)(6) 2019.According to the complainant, the shunt showed an under-drainage and adjustment difficulties.The patient underwent a revision procedure performed on (b)(6) 2023.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 58 years, weight: 67 kgs, height: 172, gender: male.

• Brand Name: PROGAV 2.0 SYS SA2.0 25 & CONTROL RES.
• 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: 18347369
• Report Number: 3004721439-2023-00386
• Device Sequence Number: 6202745
• Product Code: JXG
• UDI-Device Identifier: 04041906503239
• UDI-Public: 4041906503239
• 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: 2019
• Device Explanted Year: 2023
• 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): 12/18/2023

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: 07/04/2024
• Device Model Number: FX603T
• Device Catalogue Number: FX603T
• Device Lot Number: 20042810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 67 KG