MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV VALVE; HYDROCEPHALUS MANAGEMENT

Model Number	FV410T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav (#fx410t) was implanted during a procedure performed.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: 10 years.Weight: 10 kg.Gender: male.
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valve were detected during the visual inspection, but the measurement of the plane parallelism has confirmed with a value of - 0.008 mm [inside the tolerance of 0 ± 0.02 mm] a deformation.Permeability test: a permeability test has shown that the valve is permeable.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 valve is tested in the horizontal position.The results show that the valve operates within the accepted tolerances in the horizontal position.Adjustment test: the progav 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 did not operate as expected.The results indicate that the rotor no longer performs as required.Internal inspection : after dismantling of the valve, deposits were found in progav.To make the proteins / deposits in the valve more visible, they were colored using a staining solution.Result : in advance, we would like to point out that the product sent in was not submerged in liquid at the time of delivery.The testing of dry valves is only of limited value.The product properties can be influenced by dry residues of cerebrospinal fluid or blood.Despite this, we have examined the valve.Based on our test results, we can determine an increased braking force and visible deposits.The deposits may be the cause of the increased braking force and may have temporarily affected the functionality.The deposits had no effect on the adjustmentproperties at the time of the investigation.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 valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV VALVE
• 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: 18771960
• Report Number: 3004721439-2024-00046
• Device Sequence Number: 15365160
• Product Code: JXG
• UDI-Device Identifier: 04041906132071
• UDI-Public: 4041906132071
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/23/2024

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: 08/01/2024
• Device Model Number: FV410T
• Device Catalogue Number: FV410T
• Device Lot Number: 20034665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2017
• 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: 10 YR
• Patient Sex: Male
• Patient Weight: 40 KG