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	05/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav (#fv410t) was implanted during a procedure performed on (b)(6) 2013.According to the complainant, the shunt system was believed to be operated in overdrainage and had adjustment difficulties.The patient underwent a revision procedure performed on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 9 years.Height: 140 centimeters (cm).Weight: 45 kilograms (kg).Gender: female.
Additional Manufacturer Narrative
Investigation: visual inspection: a deformation of the outer housing of the progav valve was observed through the visual inspection.The measurement of the plane parallelism could confirm that with a value of -0,054mm the housing membrane is clearly outside tolerance (0 ± 0.02 mm).Permeability test: a permeability test has shown that the valve is permeable.Klick 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.Computer controlled test: to investigate the claim of over/under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.Due to the brake failure, the valve can´t hold the adjusted opening pressure.Therefore, the computer-controlled test is inapplicable.Internal inspection: after dismantling the valve, deposits were found in progav.Results: based on our investigation results, we can determine a defective brake as well as deposits in the valve.The observed deformation of the housing can be named as the cause of the defective brake.In addition, the visible deposits in the valve can lead to a functional impairment.Deposits caused by substances naturally present in the body, such as protein, blood or tissue particles, are one of the known and inevitable risks and side effects of hydrocephalus therapy.Even small amounts of protein can compromise 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.No further regulatory actions are required from our point of view.

• 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: 14881187
• Report Number: 3004721439-2022-00181
• Device Sequence Number: 20409914
• 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 Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

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: FV410T
• Device Catalogue Number: FV410T
• Device Lot Number: 20020061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2013
• 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: 9 YR
• Patient Sex: Female
• Patient Weight: 45 KG