MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SA25 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number FX421T

Device Problems Partial Blockage (1065); Infusion or Flow Problem (2964); Reset Problem (3019)

Patient Problem Hydrocephalus (3272)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information/investigation results will be provided in a supplemental report.

Event Description

It was reported that a progav valve had a mal-adjustment issue.A patient underwent a retro-auricular shunt system implantation on (b)(6) 2015.Sometime later, an adjustment defect was noted; and blockage and under-drainage of the valve was suspected.On (b)(6) 2019, the shunt was replaced due to malfunction.Further details were not available.

Manufacturer Narrative

Investigation visual inspection no significant deformations or damages of the valves were detected during the visual inspection.Permeability test a permeability test has indicated that the shunt assistant has a blockage and the progav valve is permeable, but has a slower flow rate than expected.Adjustment test the progav valve was tested and is adjustable to all specified pressures.However, more force was required than expected.Braking force and brake function test the brake functionality test has shown that the brake function operates as expected.However, the breaking force required was not within the specified tolerances.The measured breaking force was much higher than expected.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.Because the shunt assistant is not permeable, it was not able to be tested.The progav 2.0 valve was tested and shown to be operating outside of tolerance.Results first, we performed a visual inspection of the progav 2.0 shunt system.No significant deformations or damages of the valves were detected during the visual inspection.Next, we tested the permeability and the opening pressure of the valves.The progav 2.0 valve was permeable but the opening pressure was out of tolerance.The shunt assistant was not permeable therefore; the computer-controlled test could not be performed on it.The opening pressure of the progav 2.0 was significantly lower than expected, indicating a tendency towards over-drainage.Additionally, we tested the adjustability as well as the brake functionality and bake force of the progav 2.0 valve.The valve was adjustable, however only with difficulty.This was confirmed with the measurement of the brake force.The brake force was measured to be significantly higher tolerance.Finally, we have dismantled the valve.Inside the valve, we have found build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of under-drainage.Conversely, our investigation has shown that the valve is operating in a state of over-drainage.Additionally, we are able to confirm the presence of occlusion in the shunt assistant but not in the progav 2.0.Both malfunctions are likely due to the deposits observed inside the valve could have contributed to the compromise of the system.As described in our literature, the problem encountered is one of the known, inevitably 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 WITH SA25 AND DISTAL CATHETER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8501467
• MDR Text Key: 141523039
• Report Number: 3004721439-2019-00084
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• 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: FX421T
• Device Catalogue Number: FX421T
• Device Lot Number: 20027266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Distributor Facility Aware Date: 03/26/2019
• Device Age: 44 MO
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR