MAUDE Adverse Event Report: CHRISTOPHER METHKE GMBH & CO. KG PROGAV 2.0 VALVE; HYDROCEPHALUS VALVES

Model Number FV410T

Device Problems Obstruction of Flow (2423); Free or Unrestricted Flow (2945)

Patient Problem Failure of Implant (1924)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Expiration date: unknown.Batch number: unknown.When additional information is received, a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "underdrainage." additional patient outcome and medical intervention information has been requested.When the additional information is received, a follow up report will be submitted.

Manufacturer Narrative

Investigation: first we performed a visual inspection of the progav 2.0 valve.No significant deformations or damage of the valve were detected during the visual inspection.Next we tested the permeability, adjustability, opening pressure, brake force, and brake function of the valve.The opening pressure of the valve was out of tolerance, but all other specificaitons were met.The opening pressure was measured to be slightly lowere than expected, resulting in the tendency towards over-drainage.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of under-drainage.Conversly, our investigation has shown that the valve is operating in a state of slight over-drainage.It is likely that this is a result of the deposits observed inside the valve.As described in our literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.

• Brand Name: PROGAV 2.0 VALVE
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPHER METHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8157845
• MDR Text Key: 130169705
• Report Number: 3004721439-2018-00305
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV410T
• Device Catalogue Number: FV410T
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/17/2018
• Device Age: 5 YR
• Date Manufacturer Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Weight: 30