MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SHUNTASSISTANT 25; HYDROCEPHALUS MANAGEMENT

Model Number FX414T

Device Problem Blocked Connection (2888)

Patient Problem Failure of Implant (1924)

Event Date 02/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.Patient height: 70 cm.

Event Description

It was reported that the progav hydrocephalus valve was blocked.The patient originally underwent implantation on (b)(6) 2018.Sometime later, it was noted that the valve was blocked.Therefore, on (b)(6) 2019, the device was explanted.Additional information such as patient outcome and medical history have been requested.

Manufacturer Narrative

Manufacturing evaluation: the shunt system was received submersed in an unidentified liquid in a plastic container.Visual inspection - no significant deformations or damage of the valves were detected during the inspection.Permeability test - results have shown that the shunt assistant has a blockage and that the progav is permeable.Adjustment test - the valve was tested and was adjustable to all specified pressures.Braking force and function test - the results have shown that the brake function is fully operational and that the braking force is within the given tolerances.Results - after the tests, we have dismantled the valves.Inside the progav we have found slight deposits (likely protein).No visible deposits were seen inside the shunt assistant.Based on our investigation, we confirm the presence of occlusion in the shunt assistant valve.Despite the lack of visible deposits, it is possible that even small amounts of non-visible blood or protein inside the valves can impair the functionality of the valve and lead to the observed failure.As described in our literature, the problem encountered is one of the known, inevitable risks of hydrocephalus (hc) therapy by shunt implants.We can exlude 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 SHUNTASSISTANT 25
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8378071
• MDR Text Key: 137408735
• Report Number: 3004721439-2019-00051
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2023
• Device Model Number: FX414T
• Device Catalogue Number: FX414T
• Device Lot Number: 20038917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Distributor Facility Aware Date: 02/12/2019
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1.5 YR
• Patient Weight: 7