It was reported that there was an issue with a prosa and progav 2.0 shunt system.The reporter indicated that there the valves were explanted.The valves had been initially implanted on an unspecified date, possibly at a different health care facility.A surgeon attempted to adjust the prosa valve from 12 to 14.Verified 12 setting and after adjustment valve went to 0.Attempted several times to move valve back to 14 and it was not moving from 0 setting.The surgeon made the decision to explant valves and implant a competitor's product.Additional information has been requested.Associated medwatches: 2916714-2020-00191, 2916714-2020-00194.
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Updated information: b5 d section - serial and lot #, expiration date, explant date, manufacture date 03/14/2014 patient height 4'8 ft.Associated medwatches: 2916714-2020-00191; 2916714-2020-00194.Visual inspection we have checked for possible damages, deformations of the housing or other abnormalities.- no abnormalities are observed.Measurement of surface of the housing to verify whether the deformation had an effect on the plane-parallelism of the housing surface, this was measured using a dial gauge.The measurement of the plane parallelism confirmed the non- deformation of the visual inspection.The measured value of -0.002 mm lies within the given tolerance [0 ± 0.02mm].Permeability test: this test is carried out with the product in the horizontal position with a hydrostatic pressure difference of approx.30 cmh2o in the direction of flow.The test showed that the prosa is permeable.Adjustability test: we have investigated whether the prosa can be successfully set to each specified pressure setting.The prosa was found to be adjustable to all pressure settings.Braking force and brake function test: a specific measurement device apparatus of braking force is used to investigate the braking force and the brake function of adjustable valves.This apparatus tests whether the braking function is present and how much force must be exerted on the housing to release the rotor to adjust the valve using the integrated magnet of the braking force apparatus.The braking force of the prosa was within the specified tolerance and the brake function operated as expected.After dismantling of the valve, slightly deposits were found in prosa.Based on our investigation, we are not able to substantiate the claim of "programming issues".At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of non- visible deposits might compromise the integrity of the valve.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.From our point of view, no further regualatory actions are required.
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