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

Model Number FV410T

Device Problem Infusion or Flow Problem (2964)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the valve blocked and not adjustable.The reporter indicated that a 4 year post-operative valve is blocked and is not adjustable.The patient required explantation.Additional details of the event is not available.

Manufacturer Narrative

Investigation: visual inspection significant scratches and drainage on the outer housing of the valve were observed during the visual inspection.Permeability test a permeability test has shown that the progav valve is permeable.Adjustment test the progav 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.Results first, we performed a visual inspection of the progav valve.Significant scratches and damage to the outer housing of the progav valve were observed through the visual inspection.Next, we tested the permeability, adjustability and opening pressure of the valve, as well as the bake functionality and brake force.The pogav valve was permeable but could not be adjusted to all settings.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 valve was non-adjustable 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.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 VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9219051
• MDR Text Key: 163178168
• Report Number: 3004721439-2019-00258
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: FV410T
• Device Catalogue Number: FV410T
• Device Lot Number: 20027194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR