MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number FX413T

Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported of a malfunction query.The reporter indicated that notification was received this evening of a progav2 valve explanted query malfunction.No patient harm.No other details provided.A request for additional information has been made, however, not yet received.

Manufacturer Narrative

Investigation visual inspection except of slight scratches on the shunt assistant, no significant deformations or damage of the valves were detected during the visual inspection.Permeability test a permeability test has shown that the valves are permeable.Adjustment test the adjustment test has shown that the progav 2.0 is adjustable to all settings.For the shunt assistant the adjustment test is not applicable, because it is a valve with a fixed pressure.Braking force and brake function test the investigation of the braking force of the progav 2.0 valve showed that the brake function is fully operational and the braking force is within the given tolerances.For the shunt assistant the test is not applicable, because it is a valve with a fixed pressure.Computer controlled test to verify the suspicion of an under-drainage, the valves were tested on our miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.The progav 2.0 valve was tested in the horizontal position with an opening pressure of 5cmh2o and in the vertical position the shunt assistant was tested with an opening pressure of 20 cmh2o.The progav 2.0 valve operates within the acceptable tolerance.The shunt assistant operates outside the acceptable tolerance.Contrary to the suspected under-drainage, we can confirm an over-drainage.Results first, we performed a visual inspection of the valves.No significant deformations or damages of the valves were detected during the visual inspection.We tested the permeability of the valves.The test has shown that the valves were permeable.The testing of the adjustability, the brake functionality and as well the brake force of the progav 2.0 valve was possible and within the accepted tolerances.For the shunt assistant this tests were not applicable because it is a valve with a fixed pressure.To verify the suspicion of an over-drainage, we carried out a computer controlled test.The measured opening pressure of the progav 2.0 valve in the horizontal position was within the accepted tolerance.The measured opening pressure of the shunt system on the vertical position was outside the accepted tolerance.The valve shows an over-drainage.Finally, we have dismantled the valves.Inside the valves, we have found a build-up of substances (likely protein).Based on our investigations, we cannot confirm the suspected under-drainage.Rather, the tests have shown an over-drainage.Presumably caused by deposits inside the valve.Nevertheless, the visible deposits could have led to an under-drainage in the past.As described in our 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.Further actions no further actions are required in our point of view.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 20
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9386320
• MDR Text Key: 168300878
• Report Number: 3004721439-2019-00294
• 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: 12/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: FX413T
• Device Catalogue Number: FX413T
• Device Lot Number: 20040493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 MO