A physician reported a hakim valve (id 823100) was implanted via v-p shunt on unknown date with unknown setting.The set pressure was changed unintentionally therefore, the valve was removed and replaced on may 02, 2022.It was confirmed that the cam had fallen off from the removed valve.However, there was no cam dropout confirmed when the pressure was changed in the fluoroscopy a day before the revision.Based on information provided, it is unknown if the patient experienced any signs and symptoms due to the valve issue.Patient current status is also unknown.
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The hakim valve (id 823100) was returned for evaluation.Device history record (dhr) - lot p1380, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; the stator and the x ray dot dislodged were noted.No visible damage was noted on the valve casing.The valve could not be program tested, leak tested, reflux tested, pressure tested due to the dislodged stator.The valve was dismantled and was examined under microscope at appropriate magnification: corrosion on the stator and the x ray dot was noted.No visible damage was noted on the valve casing.The valve passes the test for occlusion.The cam magnets were controlled per process and passed successfully.The root cause for issue reported by the customer is due to the dislodged stator caused by the corrosion.The root cause of the corrosion, could not be clearly determined galvanic corrosion could not be established as a direct root cause for those valves investigated, however it was found to be a contributing factor when trauma to the valve was found.Corrosion, when it arises, only arises after long term exposure to csf.The valve has been implanted for at least 24 years.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
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