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	Hydrocephalus (3272)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
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
It was reported that an gav 2.0 (part # fx210t) was implanted during a procedure 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 the saline could not go through the device.The patient was implanted with a new m.Blue device and there were no intraoperative events that occured during the placement of the new valve.The complaint device has been received by the manufacturer for evaluation.
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.
Event or Problem Description
Patient details: age: 5 months.Weight: 9 kilograms (kg).Height: 70 centimeters (cm).Gender: male.

• 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
• 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: 14431426
• Report Number: 3004721439-2022-00133
• Device Sequence Number: 5604943
• Product Code: JXG
• UDI-Device Identifier: 04041906500009
• UDI-Public: 4041906500009
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190174
• 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: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2021
• 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: 5 MO
• Patient Sex: Male
• Patient Weight: 9 KG