MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 SYS W.CONTROL RESERVOIR 5/30; HYDROCEPHALUS MANAGEMENT

Model Number	FX148T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was a problem with a gav (b)(4).The surgeon suspected that the valve operated in overdrianage and the valve was replaced.Patient information: age: (b)(6) years, weight: unknown, height:unknown, gender: unknown.Date of implantation: (b)(6) 2020, date of removal: (b)(6) 2020."associated medwatches: 3004721439-2021-00004 , mdr # - same patient".
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: -no abnormalities are detected permeability test: the test showed that the gav 2.0 is permeable.Computer control test: the computer controlled test has shown the opening pressure of the gav 2.0, at a reference flow rate of 20 ml/h in a horizontal position, to be 5.69 cmh2o.This is within the specified tolerance of 5 cmh2o +3/-1 cmh2o.The test, performed in the vertical position at a reference flow of 20 ml/h, has shown that the gav 2.0 with a result of 26.19 cmh2o is operating not within the specified tolerance (30 cmh2o +4/-2 cmh2o).Additional testing did not significantly change the results.According to our results, we can confirm the presence of an increased flow of the test liquid.Internal inspection of product: in order to verify whether the investigated valve was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the valve.After dismantling of the valve, minimal deposits were found in gav 2.0.Results: based on our investigation, we are able to substantiate the clinical claim of "over-drainage".We are assuming that the deposits detected within the valve have caused 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.Even small amounts of non-visible deposits might 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.From our point of view, no further regulatory actions are required.
Event or Problem Description
Investigation is completed."associated medwatches: 3004721439-2021-00004, mdr#- same patient/event".

• Brand Name: GAV 2.0 SYS W.CONTROL RESERVOIR 5/30
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11230196
• Report Number: 3004721439-2021-00005
• Device Sequence Number: 3805868
• Product Code: JXG
• UDI-Device Identifier: 04041906501228
• UDI-Public: 4041906501228
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: 04/08/2025
• Device Model Number: FX148T
• Device Catalogue Number: FX148T
• Device Lot Number: 20047397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 02/26/2021
• 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: 78 YR