MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PAEDIGAV SYSTEM 9/29; HYDROCEPHALUS VALVES

Model Number FV281T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the healthcare professional,"2y 7m po valve is defect.Explanted.".

Manufacturer Narrative

Investigation: first we performed a visual inspection of the valve.No significant deformations or damage of the valve was detected during the visual inspection.Next we tested the permeability of the valve.The valve was shown to have a blockage.To test the opening pressure we would normally carry out a computer controlled test.However, because the valve is not permeable, a computer controlled test was not possible.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the valve, likely due to the deposits observed inside the valve.As described in our literature, the problem is encountered is one of the known, inevitable risks of hc-therapy by shunt implants.

• Brand Name: PAEDIGAV SYSTEM 9/29
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8148945
• MDR Text Key: 129874092
• Report Number: 3004721439-2018-00303
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K011030
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: FV281T
• Device Catalogue Number: FV281T
• Device Lot Number: 4506152409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Distributor Facility Aware Date: 12/18/2019
• Device Age: 4 YR
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention