It was reported that a progav shuntsystem (#fv427t) was implanted during a procedure.According to the complainant, the shunt system was believed to be operated in overdrainage and 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: 63 years, height: 180 cm, weight: 90 kg, gender: male.
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Investigation: visual inspection during the visual inspection a deformation of the outer housing of the progav valve could be determined.The measurement of the plane parallelism could confirm that with a value of -0.054mm - outside tolerance (0 ± 0.02 mm).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 progav is operating not within the accepted tolerance in the horizontal position.The shuntassistant is operating within the specified tolerances in both positions.An accelerated outflow of progav could be determined.Adjustment test: the progav 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 progav and shuntassistant.Results : based on our investigation results, we can determine an accelerated outflow and adjustment difficulties in the progav valve.The determined deposits can be named as the cause for the accelerated outflow and the adjustment difficulties.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.Also, we can determine deposits in the shuntassitant.The deposits had no affect to the technical properties at the time of the investigation.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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