MAUDE Adverse Event Report: CHRISTOPHER METHKE GMBH & CO. KG GAV VALVE 10/40; HYDROCEPHALUS MANAGEMENT

Model Number FV314T

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Failure of Implant (1924)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Height: 170cm.When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "9d po over drainage." additional patient information has been requested.When additional information is received a follow up report will be submitted.

Manufacturer Narrative

Investigation: visual inspection: no significant deformations or damages of the valve were detected.Permeability test: a permeability test has indicated that the valve has a blockage.Results: 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 in the valve.Due to occlusion it was not possible to test for for over drainage, however it can be postulated that the deposits could have temporarily led to a state of overdrainage in the past.As described in our literature, the problem encountered in one of the known inevitable risks of hc therapy by shunt implants.

• Brand Name: GAV VALVE 10/40
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPHER METHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8308431
• MDR Text Key: 135177994
• Report Number: 3004721439-2019-00028
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K031303
• 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: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: FV314T
• Device Catalogue Number: FV314T
• Device Lot Number: 20037022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Distributor Facility Aware Date: 02/11/2019
• Device Age: 10 MO
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 70