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

Model Number FX410T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

Height: 120 cm.When additional information becomes available a follow up report will be submitted.

Event Description

It was reported that there is an issue with over-drainage.The reporter indicated that a 2 year 10 month post-operative valve is over-draining.The device was explanted.Additional event details have not provided, however, have been requested.

Manufacturer Narrative

Investigation: visual inspection no significant deformations or damage of the valve were detected during the visual inspection.Permeability test a permeability test has shown that the progav 2.0 valve is permeable.Adjustment test the progav 2.0 valve was tested and is not adjustable throughout the normal range.Braking force and brake function test the brake functionality test has shown that the brake function is operational; however, the braking force cannot be measured due to the non-adjustability of the valve.Computer controlled test to investigate the claim of over/under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.The progav 2.0 valve is not operating within acceptable tolerances.Result: first, we performed a visual inspection of the progav 2.0 valve.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The progav 2.0 valve was permeable but could not be adjusted to all settings.The opening pressure of the progav 2.0 was significantly lower than expected, indicating a tendency towards over-drainage.Finally, we have dismantled the valve.Inside the valve, we have found a build-up of substances (likely protein).Based on our investigation, we confirm that the progav 2.0 valve was non-adjustable and was operating in an over-drainage at the time of our investigation.This is likely due to the deposits observed inside the valves.As described in our literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.The cause of the deformation of the progav 2.0 valve and the resultant defect of the rotor could not be determined through our investigation.Significant outside pressure, for example by too much force from the progav adjustment tool or by a fall or impact to the head of the patient, can 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.

• Brand Name: PROGAV 2.0 VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9744533
• MDR Text Key: 182572784
• Report Number: 3004721439-2020-00051
• 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: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Model Number: FX410T
• Device Catalogue Number: FX410T
• Device Lot Number: 20031955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 25