MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS W/SA 25 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FV435T

Device Problems Obstruction of Flow (2423); Structural Problem (2506)

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

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).When additional information is received a follow up report will be submitted.

Event Description

It was reported that po limited adjustment of valve.The explanted product were delivered to miethke with the return kit inside an unknown liquid.The file is entered with limited information.

Manufacturer Narrative

Investigation visual inspection scratches on the outer housing of the valve were observed through the visual inspection.No significant deformations or damage was detected.Permeability test a permeability test has shown that progav valve is permeable.Adjustment test the progav 2.0 valve was tested and is not adjustable through out the normal range.Braking force and brake function test.The brake functionality test has shown that the brake function is operational; however, the braking force cannot be measured due to the non-adjustability of the valve.We have dismantled the valves.Inside both valves, we have found slight build-up of substances (likely protein).Based on our investigation, we confirm the valve is non-adjustable, likely due to 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 shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV SYS W/SA 25 A.CONTROL RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8418689
• MDR Text Key: 138754864
• Report Number: 3004721439-2019-00072
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV435T
• Device Catalogue Number: FV435T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2019
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention