MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 VALVE 10/25; HYDROCEPHALUS MANAGEMENT

Model Number	FX214T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a gav 2.0 (#fx214t) was implanted during a procedure performed on an unknown date.According to the complainant, the patient was brought back for other unspecified complications.Additional information was received which indicated that the complications were unrelated to the shunt treatment.However, the physician believed additional drainage was needed, and planned to swap the device with a programmable valve.During the revision surgery, when the shunt was checked it did not "move the manometer with distal catheter still in place." however, the manometer drained at a normal rate after the valve was removed with just the distal catheter in place (still in the abdomen).The device was replaced with another manufacturer's device.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Manufacturing and quality control data: because the serial number of the device is unknown we are not able to trace production and quality control data.We confirm all parameters have been inspected and approved during the manufacturing.We assure that production and quality control ensure that only products that are conform to specifications are made available on the market.Conclusion information: an investigation was not possible because the product is not available.With reference to the reason for the complaint, we would like to point out that deposits in the valve could be responsible for the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.Due to missing information (patient data, serial number, device itself), we are unable to provide a meaningful analysis.

• Brand Name: GAV 2.0 VALVE 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: 16992609
• Report Number: 3004721439-2023-00154
• Device Sequence Number: 14322532
• Product Code: JXG
• UDI-Device Identifier: 04041906500047
• UDI-Public: 4041906500047
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2023

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 Model Number: FX214T
• Device Catalogue Number: FX214T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown