MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 SYS W/PED.CONTROL RESERV.10/25; HYDROCEPHALUS MANAGEMENT

Model Number	FX156T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a gav 2.0 with control reservoir (part # fx156t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the shunt system was believed to be blocked.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.
Additional Manufacturer Narrative
Investigation: visual inspection: bloody deposits on the product.Deposits in the control reservoir.Permeability test: a permeability test has indicated that the gav 2.0 valve has a blockage and that the control reservoir is permeable.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 valves are tested in both the horizontal as well as the vertical positions.Because the gav 2.0 valve is not permeable, a computer- controlled test is not applicable.Internal inspection: after dismantling of the valve, deposits were found in gav 2.0.Results: it should be noted that the product was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.For the sake of thoroughness and transparency, we would like to point out that a permeability test was/were already carried out after the revision at the hospital.Existing deposits in the csf can temporarily impair the function of the valves and is described as concomitant symptoms in hydrocephalus therapy.Based on our investigation, we confirm the presence of occlusion in the system at the time of investigation.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.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: GAV 2.0 SYS W/PED.CONTROL RESERV.10/25
• 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: 15323946
• Report Number: 3004721439-2022-00265
• Device Sequence Number: 12129469
• Product Code: JXG
• UDI-Device Identifier: 04041906142957
• UDI-Public: 4041906142957
• 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: 2022
• 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): 08/30/2022

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: FX156T
• Device Catalogue Number: FX156T
• Device Lot Number: 20055858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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: 4 MO
• Patient Sex: Female