Investigation: visual inspection: during the investigation, deposits on the device were determined.Permeability test: a permeability test has shown that the valve is 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 valve is tested in the horizontal position.The results show that the valve does not operate within the accepted tolerances in the horizontal position.An accelerated outflow is 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 valve, deposits were found in progav.Result : based on our investigation results, we can determine an accelerated outflow and a non- adjustability of the valve.The determined deposits can be named as the cause for the functional deviations.Organic material 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 valve 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 (#fv410t) was implanted during a procedure performed on (b)(6) /2022.According to the complainant, the valve 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: 19 months, height: 82.4 cm, weight: 11.1 kg, gender: female.
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