Expiration date 06/30/2018.Implant and explant date: (b)(6) 2014 and (b)(6) 2018.Production date 11/15/2013.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 - a permeability test has shown that the progav valve is permeable.Adjustment test - the progav valve was tested and is adjustable to all specified pressures.Braking force and brake function test - the brake functionality test has shown that the brake function operates as expected.However, the breaking force required was not within the specified tolerances.Computer controlled test - to investigate the claim of over/under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The progav valve is not operating within acceptable tolerances.Results finally, we have dismantled the valve.Inside the valve we have found slight build-up of substances (likely protein).Based on our investigation, we confirm that the progav valve was operating in an over/under-drainage state at the time of our investigation.This is likely due to the deposits observed inside the valves.As described in our literature, the problem encountered is one of the known, inevitable risk of hydrocephalus therapy by shunt implants.We can exlude a defect at the time of release.The valve met all specifications of the final inspection when released.
|