MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA15 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FX426T

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that post operatively the shape didn't return to original position.The reporter indicated when the product was pressed for adjustment, the button did not return to the original position.(it remained dented.) however, when the surgeon checked and touched the product several times after revision the button returned to the original position.The event was confirmed when the shunt reconstruction was implemented because of the expose of the tube caused by skin ulcer on the shunt tube running part on the left auricle.Additional details of the event have been requested.

Manufacturer Narrative

Additional information: height: 112.5cm.Investigation: visual inspection: in the first step of our investigations, we carried out a visual test on the valve.Permeability test: to proof the penetrability of the shunt system we have carried out penetrability test.This test is carried out at a hydrostatic pressure of approximately 20-30 cmh2o in the direction of flow.Adjustment test: to proof the penetrability of the shunt system we have carried out penetrability test.This test is carried out at a hydrostatic pressure of approximately 20-30 cmh2o in the direction of flow.Braking force and brake function test: to measure the braking force, we tested the progav 2.0 valve with a braking force device.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 device.Results: firstly, we would like to point out that the period between the date of removal ((b)(6) 2019) and investigation (16.01.2020) is very long and that we received the progav 2.0 shunt system dry without liquid.The investigation of a dry shunt system is not meaningful/valuable, since dry deposits of cerebrospinal fluid and blood can impair the product properties.Scratches on the outer casing of the progav 2.0 were observed through the visual inspection.No other significant deformations or damage was detected.Next, we tested the permeability of the valves.Both valves were shown to be non-permeable, indicating blockages.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 slight build-up of substances (likely protein).Based on our investigation, we are confirming the claim of blockage, but a damage of the progav 2.0 housing or adjustment problem we are unable to confirm.The progav 2.0 was adjustable to all settings as specified and the brake function is fully operable.Probably the blockage is due to dry protein deposits in the valves.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/SA15 A.SPRUNG RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9353870
• MDR Text Key: 167348308
• Report Number: 3004721439-2019-00291
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2023
• Device Model Number: FX426T
• Device Catalogue Number: FX426T
• Device Lot Number: 20038861
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Weight: 23