MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 LP U-FORM WITH DIST.CATH.5/35; HYDROCEPHALUS MANAGEMENT

Model Number	FX231T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation was not possible because no sample was sent for investigation.On the basis of the product documentation, we can exclude the presence of a defect at the time of delivery of the valve, since this documentation indicates that the valve is in perfect condition.It is possible that protein deposits inside the valve affect the function of the gav® 2.0 valve and have led to an over-drainage.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.However, we cannot finally clarify what influenced the over-drainage, this would be require an examination of the valve.Further actions: based on the current information, no further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a gav 2.0 valve (part # fx231t) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the valve was believed to be operating in overdrainage.The patient underwent a revision procedure on (b)(6) 2020.The complaint devices were not returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• Brand Name: GAV 2.0 LP U-FORM WITH DIST.CATH.5/35
• 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: 13876552
• Report Number: 3004721439-2022-00060
• Device Sequence Number: 14582738
• Product Code: JXG
• UDI-Device Identifier: 04041906501051
• UDI-Public: 04041906501051
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2022

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 Expiration Date: 05/19/2025
• Device Model Number: FX231T
• Device Catalogue Number: FX231T
• Device Lot Number: 20047918
• 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: 02/22/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2020
• 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 Sex: Unknown