It was reported that a progav 2.0 shuntsystem (#fx643t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system caused a blockage 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: 1 year, 4 months, height: 70 cm, weight: 10 kg, gender: male.
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Investigation: visual inspection: during the investigation, no significant deformations or damage of the valve were determined.Permeability test: a permeability test has shown that the progav 2.0 is blocked while the shuntassistant 2.0 is permeable.Computer controlled test: to investigate the claim of blockage, 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.Because the progav 2.0 valve is not permeable, a computer control test is not possible.The shuntassistant 2.0 does not operate within the specified tolerances in the vertical position.An accelerated outflow of shuntassistant 2.0 could be determined.Adjustment test: the progav 2.0 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 and the braking force is within the given tolerances.Internal inspection : after dismantling of the valves, deposits were found in both.Results : based on our investigation results, we can determine a blockage in the progav 2.0 valve.The shuntassistant 2.0 showed an accelerated outflow in the vertical position.The determined deposits can be named as the cause for the functional deviations.Organic matter 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.
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