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

Model Number FV435T

Device Problems Blocked Connection (2888); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that 6y po valve is blocked.Explanted.Delivered with the return kit inside an unknown liquid.

Manufacturer Narrative

Implant date: unknown month and day in 2012.Investigation: visual inspection a deformation of the outer housing of the progav valve was observed through the visual inspection.Permeability test a permeability test has shown that the progav valve is permeable.Adjustment test the progav valve was tested and is adjustable to all specified pressures.Braking force and brake function test the brake functionality test has shown that the brake function is operational and the braking force is within the given tolerances.Results first, we performed a visual inspection of the progav valve.A deformation of the outer housing of the progav valve was observed through the visual inspection.Next, we tested the permeability, adjustability and opening pressure of the valve, as well as the brake functionality and brake force.The progav valve operates as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we have found slight build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of occlusion.At the time of our investigation, the progav was shown to be permeable.This is likely due to the 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 valve 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: PRO GAV
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, D-144 69; GM D-14469
• MDR Report Key: 7612029
• MDR Text Key: 111820142
• Report Number: 3004721439-2018-00105
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: FV435T
• Device Catalogue Number: FV435T
• Device Lot Number: 4504190366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Distributor Facility Aware Date: 05/23/2018
• Device Age: 6 YR
• Date Manufacturer Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 60