Investigation: visual inspection: during the investigation, no significant deformations or damage of the valves were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the both valves are not operating within the acceptable tolerance in horizontal position.An accelerated outflow of progav 2.0 and a slower outflow of the shuntassistant 2.0 in the horizontal position could be determined.Adjustment test: the progav 2.0 was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function is operational.However, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection : after dismantling of the valves, deposits were found in both valves.Results : based on our investigation results, we can determine a deviation of the outflow and adjustment difficulties.The determined deposits can be named as the cause for the functional deviations.Organic deposits in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
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It was reported that a progav 2.0 shuntsystem (#fx6436t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the shunt system caused an overdrainage and had adjustment difficulties.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 4 years, 2 months.Weight: 20 kg.Gender: female.
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