MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SHUNTASSISTANT 2.0 25; HYDROCEPHALUS MANAGEMENT

Model Number FX643T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there is an issue with valve blockage and under drainage.The reporter indicated that a 4 month 30 day post-operative valve is blocked and is under draining.The device was explanted.Additional event details and patient information have not provided, however, have been requested.

Manufacturer Narrative

Investigation.Visual inspection: in the first step of our investigations a visual inspection is performed.It is tested whether any defects, deformations or other abnormalities are to be detected.Permeability test: to proof the penetrability of the shunt system we have carried out a penetrability test.This test is carried out at a hydrostatic pressure of approximately of 30 cmh2o in the direction of flow.Computer controlled test: the test is performed with a miethke computer controlled testing apparatus.The progav 2.0 shunt system was tested by simulating a cerebrospinal fluid flow at rates between 60ml/h down to 5 ml/h in the horizontal and vertical position (in acc.To iso 7197).Distilled water is used as test-liquid.Adjustment test: our adjustment 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 significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability of the progav 2.0 shunt system.The investigation has shown that the progav 2.0 shunt system was permeable.The control reservoir was also positive tested for permeability and had no problems by pumping.To investigate the suspicion of an underdrainage the opening pressure is measured by using a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.The progav 2.0 was tested in the horizontal position.At a set opening pressure of 0 cmh2o the opening pressure in the horizontal position was measured at 1,04 cmh2o at a reference flow level of 20 ml/h.The progav 2.0 valve operates within the acceptable tolerance.The shunt assistant 2.0 was tested in the vertical position.At fixed opening pressure of 25 cmh2o the opening pressure in the vertical position was measured at 12,40 cmh2o at a reference flow level of 20 ml/h.The valve is not operating within the acceptable tolerance.A second test was done.The opening pressure in the second test was measured at 9,39 cmh2o.There was no significant improvement in the values.Contrary to the suspected underdrainage, the shunt assistant shows an over drainage.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 of the progav 2.0 valve.The results show that the brake function is fully operational and the braking force is within the given tolerances.Finally, we have dismantled the valves.Inside the valves, we have found a build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of an underdrainage and blockage at the time of our investigation.Contrary to the suspected underdrainage, the shunt assistant shows an over drainage.This is likely due to the deposits observed inside the valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.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.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 2.0 25
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9787156
• MDR Text Key: 182017038
• Report Number: 3004721439-2020-00055
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K190174
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX643T
• Device Catalogue Number: FX643T
• Device Lot Number: 20042338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 MO