MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PED.W/SA25 A.BURRHOLE RES; HYDROCEPHALUS MANAGEMENT

Model Number FX449T

Device Problem Infusion or Flow Problem (2964)

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

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

Investigation evaluation: on-going.When additional information becomes available a follow up report will be submitted.Re-submission of this mdr due to incorrect initial mdr number of 3004721439-2019-00236.This mdr was submitted on 05 sept 2019 and acknowledgements passed, however, the correct mdr number for this complaint is 3004721439-2019-00233.

Event Description

It was reported that the valve was blocked.The reporter indicated that a postoperative valve is blocked and required explantation.Additional details of the event have not been provided.

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 indicated that both valves have blackages.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.Results it should be noted that the shunt system was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry depositis of kiquor and blood can have on product performance.In spite of this, we have investigation the system to the vest of our abilities.First, we performed a visual inspection of the progav 2.0 shunt system.No significant deformation or damage of the valves were detected during the visual inspection.Next, we tested the permeability and opening pressure of the valves.Both valves were shown to be non-permeable, indicating blockage.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav 2.0 valve.The valve operated as expected and met all specifications.Finally, we have dismantled the valves.Inside both valves we have found significant build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the system at the time of 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 2.0 SYS PED.W/SA25 A.BURRHOLE RES
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9120712
• MDR Text Key: 160132701
• Report Number: 3004721439-2019-00233
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2023
• Device Model Number: FX449T
• Device Catalogue Number: FX449T
• Device Lot Number: 20038430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Date Manufacturer Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 MO