MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.; HYDROCEPHALUS MANAGEMENT

Model Number FX434T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/22/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that there is an issue with valve.The reporter indicated that a post-operative valve has valve failure.The device was explanted.Per the reporter, "the valve was placed in a patient in the month of (b)(6) 2019, then in (b)(6), the patient retuned to have a cochlear implant and the valve bagan to fail (as it was locked) and did not pass liquid." additional event details and patient information was not provided, however, has been requested.

Manufacturer Narrative

Investigation.Visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: to proof the penetrability of the shunt system we have carried out penetrability test.The test carried out at a hydrostatic pressure at horizontal position in the direction of flow.Adjustment test: our adjustment tests are carried out with the standard progav 2.0 checkmate and measurement tool.The progav 2.0 is adjusted from 0 to 20 cmh2o and down again in increments of 5 cmh2o.Braking force and brake function test: to measure the braking force, we tested the progav 2.0 valve with a braking force apparatus.Here it is measured how much force must be exerted on the housing to release the rotor to adjust the valve by the integrated magnet of the braking force apparatus.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 deposits of liquor and blood can have on product performance.In spite of this, we have investigated the system to the best of our abilities.First, we performed a visual inspection of the progav 2.0 shunt system.No significant deformations or damage of the valves were detected during the visual inspection.To investigate the suspected blockage, we tested the permeability of the shunt system at a hydrostatic pressure difference of 30cmh2o in horizontal flow direction.The test result shown that the shunt system has blocked.To receive further information about which valve resulted in the blockage of the system, we tested the progav 2.0 and the shunt assistant individually for permeability.The test showed that the progav 2.0 is blocked.To ensure that the progav 2.0 valve is adjustable we tried to adjust the valve from 0cmh2o to 20 cmh2o and down again in increments of 5cmh2o.The valve was not fully adjustable to specifications.Next, we tested the braking force and brake functionality.The brake function is operational; however, the braking force cannot be measured due to the non-adjustability of the valve.In order to verify whether the progav 2.0 shunt system is compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood or tissue particles).In the cerebrospinal fluid, we have dismantled the valves.Inside both valves, we have found build-up of substances (likely protein).It was found, that the protein deposits in the progav 2.0 are dry.Based on our investigation, we confirm the blockage of the shunt system.In addition, we confirm that the progav 2.0 valve is non-adjustable.We suspected that the malfunctions was likely due to build-up of protein deposits.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 shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9843178
• MDR Text Key: 188551265
• Report Number: 3004721439-2020-00072
• 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: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2024
• Device Model Number: FX434T
• Device Catalogue Number: FX434T
• Device Lot Number: 20040405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention