MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA15 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FX426T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Event Description

It was reported that there is an issue with valve.The reporter indicated that a post-operative valve was not flowing properly.Per the reporter, the symptoms of the patient were going well for about a year after the surgery, but at the end of february, the patient felt a headache.Ventricle enlargement was confirmed and the surgeon tried to lower the pressure of the product; however, it did not work properly.Then, the contrast agent inspection was carried out and it was found that the valve was not blocked completely but the flow was not well.The device was explanted.Additional event details and patient information have been requested.

Manufacturer Narrative

Investigation: visual inspection: during the visual investigation, it is verified whether the returned product has any defects, deformations or other deviations.Permeability test: to proof the penetrability of the shunt system we have carried out permeability test.This test is performed at a hydrostatic pressure of approximately 30 cmh2o in the horizontal direction of flow.Computer controlled test: the test is performed with a miethke computer controlled testing apparatus.The valves are tested by simulating a cerebrospinal fluid flow at rates between 60 ml/h down to 5 ml/h with the valves in both vertical and horizontal position (in acc.To iso 7197).Distilled water is used as the test-liquid.Adjustment test: the adjustment test is used to ensure that the valve can be adjusted to all pressure levels.The tests are carried out with the standard progav 2.0 checkmate and measurement tool.The valve is adjusted from 0 to 20 cmh2o and down again in increments of 5 cmh2o.Braking force and brake function test: to measure the braking force, we tested the progav 2.0 valve with a braking force apparatus.Here it is measured how much force must be exerted on the housing to release the rotor to adjust the valve by the integrated magnet of the braking force apparatus.Results: first, we performed a visual inspection of the progav 2.0 shunt system.No further damage or abnormalities were visible except deposits at the inlet spout of the shunt system.Secondly, we tested the permeability of the shunt system.The test result show that the progav 2.0 shunt system is permeable.Next, we performed a computer controlled simulated flow test.The opening pressure is expected to measure at the reference flow rate of 20 ml/h in the horizontal position [progav 2.0 - tolerance 0 ± 3 cmh2o] and in the vertical position [shunt assistant - tolerances 16 ± 3 cmh2o].The opening pressure of the progav 2.0 in the horizontal position at a reference flow level of 20 ml/h was measured at 0.53 cmh2o.The valve operates within the accepted tolerance.[tolerances 0 ± 3 cmh2o].The opening pressure of the shunt assistant (15cmh2o) in the vertical position at a reference flow level of 20 ml/h was measured at 14.90 cmh2o.The valve operates within the accepted tolerance.[tolerances 16 ± 3 cmh2o].To ensure that the progav 2.0 valve is adjustable we tried to adjust the valve from 0cmh2o to 20 cmh2o and down again in increments of 5 cmh2o.The valve was adjustable to all settings.Next, we tested the braking force and brake functionality.The results show that the brake function is fully operational and the braking force is within the given tolerances.In order to verify whether the valves were compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood or tissue particles)1 in the cerebrospinal fluid, we have dismantled the valves.There were no visible deposits inside the valves.However even a small amount of blood or protein that is not visible can lead to temporary blockage and could be responsible for the suspected malfunction in the past.Based on our investigation, we are unable to substantiate the claim of under-drainage.The progav 2.0 shunt system operate within all specified tolerances.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.Further actions: no further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 SYS W/SA15 A.SPRUNG RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9913211
• MDR Text Key: 188554534
• Report Number: 3004721439-2020-00075
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2023
• Device Model Number: FX426T
• Device Catalogue Number: FX426T
• Device Lot Number: 20039186
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention