MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV SYSTEM W/PRECHAMBER ON VALVE 5/30; HYDROCEPHALUS VALVES

Model Number	FV340T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation results: optical inspection: first step of our investigation is the optical inspection.The visual inspection revealed that the gav valve has no deformations or other abnormalities.Permeability test: to proof the penetrability of the valve we carried out a penetrability test.This test was carried out at a hydrostatic pressure of approx.30 cmh2o in the flow direction.The test results that the valve was more difficult penetrable.Adjustment test: an adjustment test is not applicable, because the valve has a fixed pressure level.Braking force and brake function test: a braking force and brake function test is not applicable, because the valve has a fixed pressure level.Computer controlled test: this test is performed with a miethke computer controlled testing apparatus which simulates a liquor flow between 60 ml/h down to 5 ml/h and up again to 60 ml/h (in acc.To iso 7197).Distilled water used as becomes test fluid.Result: first of all we want to point out that we received the valve dry in an plastic container (without liquid).The investigation of a dry valve is not significant because dry deposits of liquor and blood can affect the product performance.In spite of this, we still decided to investigate the valve.In the visual inspection of the valve, we could not detect any apparent damage.In the further course of the investigation, we tested the permeability of the gav valve.The test results that the valve was more difficult penetrable.In order to check the assumed over-drainage, we carried out a computer controlled test.Horizontal position: at a set opening pressure of 5/30 cmh2o, a resulting pressure in a lying body position of 5 cmh2o is to be expected.The measurement showed that the valve is within the tolerance (5 cmh2o ± 2 cmh2o) in the reference flow range of 5 ml / h in the horizontal body position with a value of 6,86 cmh2o.Vertical position: at second the gav was tested in the upright position.Based on the opening pressure of 30 cmh2o in upright position an opening pressure of 0 cmh2o is expected.(the pressure resulting from the difference of altitude is being compensated by the valve.) the accepted tolerance range for the opening pressure of 30 cmh2o in upright position is 0 ± 4 cmh2o.The measured opening pressure of -6,82 cmh2o was clearly below the accepted tolerance range.Therefore, we have the performed a second test.The second test showed even a deterioration at a value with -9,21 cmh2o ( 0 ± 4cmh2o) we can confirm the suspicion of one over-drainage according to our measurements.As a final examination we decided to dismantle the valve.Inside the valve we found visible deposits that may have caused the assumed over-drainage.In our point of view there is no failure detectable with the valve at the time of delivery.In addition, the over-drainage is a know and unchangeable risk of hc-therapy by shunts.
Event or Problem Description
It was reported that agav system w/prechamber on valve 5/30 (fv340t) was implanted during a procedure performed on unknown date.According to the complainant, the gav system was believed to be overdrainage.Also mentioned that the valve stopped working 3 years after being placed.The patient underwent a revision procedure on (b)(6) 2016.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Patient information: age: (b)(6) years, weight : (b)(6) kg, height: 160 cm.

• Brand Name: GAV SYSTEM W/PRECHAMBER ON VALVE 5/30
• Common Device Name: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12518454
• Report Number: 3004721439-2021-00651
• Device Sequence Number: 5174590
• Product Code: JXG
• UDI-Device Identifier: 04041906131715
• UDI-Public: 4041906131715
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K031303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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 Model Number: FV340T
• Device Catalogue Number: FV340T
• Device Lot Number: 20021786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2016
• Initial Report FDA Received Date: 09/23/2021
• 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: 67 YR
• Patient Weight: 60