MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 VALVE 5/20; HYDROCEPHALUS MANAGEMENT

Model Number	FX210T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a gav 2.0 valve 5/20 (part # fx210t ) was implanted during a primary procedure performed in (b)(6) 2021.According to the complainant, initially the shunt was noted to be overdraining and the shunt pressure was low but during post operative visits it was noted that the device did not seem to be draining.The patient underwent a revision procedure on (b)(6) 2022 when the shunt was cycled with saline the surgeon noted that that the saline could not go through the device.The patient was implanted with a new m.Blue device, there were no intraoperative events that occured during the placement of the new valve.The complaint device has not been received by the manufacturer for evaluation.The malfunction is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
Patient details: age: 5 months.Weight: 9 kilograms (kg).Height: 70 centimeters (cm).Gender: male.
Additional Manufacturer Narrative
Investigation: visual inspection: - third-party catheter with deposits inside.Permeability test: the test showed that the gav 2.0 with the third-party catheter is non-permeable.To exclude a blockage in the catheter we disconnected it and tested the gav 2.0 individually once again.The test showed that the gav 2.0 is not permeable.Computer control test: due to the non-permeability of the valve, the computer-controlled test is not applicable.Internal inspection of product: after dismantling of the valve, deposits were found in gav 2.0.Results: we would like to note in advance that the returned product was not submerged in liquid at the time of receipt.The testing of valves sent in a dry condition is only of a limited value.The product performance can be affected by dry residues of cerebrospinal fluid or blood.Despite this we have tested the device to the best of our abilities.For the sake of thoroughness and transparency, we would like to point out that a permeability test was already carried out after the revision at the hospital.Based on our investigation results, we have determined that there was a blockage in the valve at the time of our investigation.Detected deposits could be named as the cause of the blockage.Existing deposits in the csf may temporarily impair the function of the valve and are described concomitants in the hydrocephalus therapy.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.From our point of view, no further regulatory actions are required.

• Brand Name: GAV 2.0 VALVE 5/20
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 14320233
• Report Number: 2916714-2022-00049
• Device Sequence Number: 12046313
• Product Code: JXG
• UDI-Device Identifier: 04041906500009
• UDI-Public: 4041906500009
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022
• Report Date (Section F): 05/06/2022

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: 01/27/2026
• Device Model Number: FX210T
• Device Catalogue Number: FX210T
• Device Lot Number: 20051596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/19/2022
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/10/2022
• 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: 5 MO
• Patient Sex: Male
• Patient Weight: 9 KG
• Date Report Sent to FDA: 05/06/2022