It was reported that a progav 2.0 (#fx441t) was implanted during a procedure performed on (b)(6) 2019.According to the complainant, the shunt system was believed to be operated in under-drainage 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: 79 years, height: 168 cm, weight: 72 kg, gender: male.
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Investigation: visual inspection during the investigation, no significant deformations or damage of the valve was determined.Permeability test a permeability test has shown that the valve is permeable.Computer controlled test to investigate the claim of under-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 operates within the accepted tolerances in the horizontal position.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 valve, deposits were found in progav 2.0.Result based on our investigation results, we can determine adjustment difficulties in the valve.The determined deposits can be named as the cause for the adjustment difficulties.Proteins 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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