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

Model Number FV701T

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

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

Event Description

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

Manufacturer Narrative

Investigation: visual inspection: no significant deformations or damage of the valve was detected during the visual inspection.Permeability test: a permeability test has shown the prosa valve is permeable.Adjustment test: the prosa 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 bake function is fully operational and the braking force is within the given tolerances.Results first, we performed a visual inspection of the prosa valve.No significant deformations or damage of the valve was detected during the visual inspection.Next, we tested the permeability and opening pressure of the valves.Both valves were shown to be permeable.Additionally, we tested the adjustability, adjustability and opening pressure of the valve, as well as the brake functionality and brake force.The prosa valve was permeable but could not be adjusted to all settings.Finally, we have dismantled the valve.Inside the valve, we have found minimal build-up of substances (likely protein).Based on our investigation, we confirm that the prosa valve could not be adjusted to all settings.This is likely due to the deposits observed inside the valves.These deposits could have led to a temporary blockage.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 shunt system met all specifications of the fin inspection when release from christoph miethke gmbh & co.Kg.

• Brand Name: PROSA VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9219047
• MDR Text Key: 163178030
• Report Number: 3004721439-2019-00256
• 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: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20027594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention