MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SHUNTASSISTANT 25; HYDROCEPHALUS VALVES

Model Number FX414T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 10/05/2018

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 to the company sales representative "3m po valve is blocked.Explanted.".

Manufacturer Narrative

The shunt system was received submerged in an unidentified liquid in a plastic container.No deformation or damage of the valves were detected during the visual inspection.The permeability test has indicated that both the progav 2.0 valve and the shunt assistant are permeable.However, the shunt assistant drained slower than expected, indicating a partial blockage.Both valves discharged bloody fluid during the test.The progav 2.0 valve was tested and is adjustable to all specified pressures.The brake functionally test has shown that the brake function is fully operational and the braking force is with the given tolerances.We performed a visual inspection of the progav2.0 shunt system.No deformation or damage of the valves were detected during the visual inspection.Next we tested the permeability of the valves.The progav 2.0 valve was shown to be permeable.The shunt assistant, while permeable drained slowly indication a partial blockage.Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav 2.0 valve.The valve operated as expected and met all specifications.Finally, we have dismantled the valve.Inside the progav2.0 valve we have found a buildup of bloody substance likely protein.Additionally, we observed slight deposits within the shunt assistant.Based on our investigation, we confirm the presence of occlusion in the shunt system, likely due to the deposits observed in both valves.We can exclude a defect at the time of release.The valve met all specifications of the final inspections.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 25
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8053414
• MDR Text Key: 126630131
• Report Number: 3004721439-2018-00268
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2023
• Device Model Number: FX414T
• Device Catalogue Number: FX414T
• Device Lot Number: 20037612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Distributor Facility Aware Date: 11/26/2018
• Device Age: 7 MO
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Weight: 7