MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG GAV VALVE 5/30; HYDROCEPHALUS MANAGEMENT

Model Number FV310T

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hydrocephalus (3272)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the shunt system.The patient was initially implanted with a gav valve.Postoperatively, there was an unspecified dysfunction.Due to the malfunction, the valve was explanted on (b)(6) 2019.Additional information was not provided.

Manufacturer Narrative

Manufacturing evaluation: the valve was received dry (not submersed in liquid as suggested).Visual inspection - no significant deformations or damage of the valve were detected during the visual inspection.Permeability test - results have shown that the valve has a blockage.Adjustment test - this is a fixed pressure valve.An adjustment test is n/a.Braking force and function test - this test is n/a.Results - it should be noted that the valve was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.After the tests, we have dismantled the valve.Inside the valve we found a build-up of substances (likely protein).Based on our investigation, we detect a presence of occlusion in the valve, 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 (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.

• Brand Name: GAV VALVE 5/30
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9136837
• MDR Text Key: 166157989
• Report Number: 3004721439-2019-00252
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: FV310T
• Device Catalogue Number: FV310T
• Device Lot Number: 20035592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR