Manufacturing and quality control data: all parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Inspection: visual inspection: a deformation of the outer housing of the progav was observed through the visual inspection.No deformation or damage of the shunt assistant was observed.The progav housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at 0.1470mm, outside the tolerance of 0 +/- 0.02mm.Permeability test: a permeability test has indicated that the shunt assistant has a blockage and the progav is permeable.Adjustment test: the progav was tested and is not adjustable throughout the normal range.The valve was found to be non-adjustable in the lower range between 0-8 cmh2o, but fully adjustable in the upper range, between 8-20 cmh2o.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the breaking force was not able to be measured due to the non-adjustablilty of the progav.Results: we have dismantled the valves.Inside both valves we have found a build-up of substances (likely protein).Based on our investigation, we can confirm that the progav is non-adjustable and the shunt assistant valve is occluded, both likely due to the deposits observed inside the valves.As described in our literature, the problems encountered are of the known, inevitable risks of hc-therepy by shunt implants.
|