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

Model Number FX410T

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a valve under drains and is not adjustable.The reporter indicated that a 1 year 3 month post operative valve under drains and is not adjusting.The device was explanted.Additional event details have not been provided.

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 that the progav 2.0 valve is permeable.Adjustment test: the progav 2.0 valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Computer controlled test: to investigate the claim of 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 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 was 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 operates as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we have found slight build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of non-adjustability and under-drainage.At the time of our investigation, the progav 2.0 was able to be adjusted to all specified settings and is operating within acceptable tolerances.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.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 VALVE
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9422696
• MDR Text Key: 185495925
• Report Number: 3004721439-2019-00309
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: FX410T
• Device Catalogue Number: FX410T
• Device Lot Number: 20037987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Weight: 34