MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number	FX413T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: during the investigation, scratches on the outer housing of the valve, but no significant deformation or damage was determined.Permeability test: a permeability test has shown that the progav 2.0 is permeable while the shuntassistant has a blockage.Computer controlled test: to investigate the claim of over-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The progav 2.0 valve is tested in the horizontal position.The results show that the progav 2.0 does not operate within the accepted tolerance in the horizontal position.Shuntassistant is not permeable, a computer control test is not applicable.An accelerated outflow of progav 2.0 could be determined.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 operates as expected.However, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection : after dismantling of the valves, deposits were found in both valves.Summary of the investigation results: based on our investigation results, an accelerated outflow and a non-adaptability at the progav 2.0 valve were determined.The shuntassistant was found to be clogged.The visible deposits in the valves caused 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.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx413t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the shunt system caused an overdrainage and had adjustment difficulties.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 6 years.Height: 104 cm.Weight: 15 kg.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 20
• 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: 19930392
• Report Number: 3004721439-2024-00229
• Device Sequence Number: 11453221
• Product Code: JXG
• UDI-Device Identifier: 04041906136550
• UDI-Public: 4041906136550
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 08/07/2024

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: 01/08/2025
• Device Model Number: FX413T
• Device Catalogue Number: FX413T
• Device Lot Number: 20045405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• 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: 6 YR
• Patient Sex: Unknown
• Patient Weight: 15 KG