MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number FV251T

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

Patient Problems Failure of Implant (1924); Hydrocephalus (3272)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient information: height cm: 160.When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "4 year 11 month po overdrain of the valve." additional patient information has been requested.When additional information is received a follow up report will be submitted.All medwatch submissions related to this patient are: 3004721439-2019-00056, 3004721439-2019-00057 (this report).

Manufacturer Narrative

Manufacturing site evaluation: the shunt system was manufactured by a qualified employee; deviations during assembly did not occur.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Investigation - the shunt system was received submersed.No significant deformations or damage of the valve were detected during the visual inspection.Permeability test- the test has shown that the valve is permeable.The flow rate was slower than expected.Adjustment test - this is a fixed pressure valve.An adjustment test was not applicable.Braking force and brake function test - this is a fixed pressure valve.A braking force and brake function test is not applicable.Computer controlled test - to investigate the claim of over-drainage, the opening pressure is measured using a testing apparatus which simulates a cerebrospinal fluid (csf) flow.The valve is tested in the vertical position and was tested twice.The first results showed that the valve was not operating within the acceptable tolerance.Upon a seond test, the opening pressure value moved just within tolerance.This was likely due to a clearing out of the valve due to the nature of the test.Results - after the tests, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we confirm that the valve was operating in an over-drainage state, likely due to the deposits observed inside the valve.As described in our literature, the problem encountered is one of the known, inevitable risks of hydrocephalus 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: SHUNTASSISTANT 20
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, 14469 ; GM 14469
• MDR Report Key: 8384020
• MDR Text Key: 137662079
• Report Number: 3004721439-2019-00057
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: FV251T
• Device Catalogue Number: FV251T
• Device Lot Number: 4503261549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Distributor Facility Aware Date: 03/13/2019
• Device Age: 8 YR
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 30