MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 VALVE 10/30; HYDROCEPHALUS MANAGEMENT

Model Number	FX215T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: some particles in the delivery liquid, deposits on the valve, but no significant deformations or other abnormalities of the valve were detected during the visual inspection.Permeability test: a permeability test has indicated that the valve has a blockage.Results: first, we performed a visual inspection of the gav 2.0.Some particles in the delivery liquid, deposits on the valve were detected during the visual inspection.Next, we tested the permeability of the valve.The valve was shown to have a blockage.The computer controlled test could not be performed, because the detected blockage in the valve.Finally, we have dismantled the valve.Inside the valve we have found no visible build-up of substances (likely protein), but in the outlet are some proteins visible.Based on our inspection results, we are able to detect a blockage in the valve at the time of our investigation.We suspect that the deposits found in the outlet of the valve have led to the functional impairment.Deposits caused by substances naturally present in the csf, such as protein, blood, or tissue particles, are among the known and unavoidable 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.
Event or Problem Description
It was reported that a gav 2.0 (part # fx215t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the shunt system was believed to be operated in underdrainage.The patient underwent a revision procedure on (b)(6) 2021.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6).Height: 41.5 centimeters (cm).Weight: (b)(6).Gender: female.

• Brand Name: GAV 2.0 VALVE 10/30
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12341716
• Report Number: 3004721439-2021-00227
• Device Sequence Number: 14586573
• Product Code: JXG
• UDI-Device Identifier: 04041906500054
• UDI-Public: 4041906500054
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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: 02/11/2026
• Device Model Number: FX215T
• Device Catalogue Number: FX215T
• Device Lot Number: 20051858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 MO
• Patient Weight: 9