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

Model Number FX410T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Implant date: (b)(6) 2008 (day unknown).When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "10y 7m po overdrainage of the valve.Explanted.".

Manufacturer Narrative

All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.A deformation of the outer housing of the progav was observed through the visual inspection.The progav housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at -0.720mm, outside the tolerance of 0+/-0.02mm.A permeabiltiy test has shown that the progav valve is permeable.The progav was tested and is adjustable to all specific pressures.The brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.To test the opening pressure, we used a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.The test has shown that the progav is not operating within acceptable tolerances.We have dismanteled the valve.Inside the valve we have found a slight build up of substances (likely protein).Based on out investigation, we are unable to substantiate the claim of over-drainage.In contrast, our investigation shows that the valve is operating in an under-drainage state, likely due to the deposits observed inside the valve.As described in our literature, even a small amount of blood or protein can lead to a temporary blockage and could be responsible for the suspected malfunction.This is one of the known, inevitable risks of hc-therapy by shunt implants.

• Brand Name: PROGAV VALVE
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPHER METHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8157938
• MDR Text Key: 130165066
• Report Number: 3004721439-2018-00295
• 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: 12/27/2018

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 Expiration Date: 06/30/2012
• Device Model Number: FX410T
• Device Catalogue Number: FX410T
• Device Lot Number: 4501070419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Distributor Facility Aware Date: 12/11/2018
• Device Age: 11 YR
• Date Manufacturer Received: 12/11/2018
• 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: 48