A facility reported a hakim valve (unknown product id) was implanted due to acqueductal stenosis in 2004.The radiologist was not able to visualize the radiographic marker to determine the setting; therefore, the valve was explanted on (b)(6) 2022, and upon removal, it was determined that there was no proximal flow.An endoscopic third ventriculostomy was done to follow pressures.As per neuro exam patient was doing well.
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The hakim valve was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.However, a probable root cause for the reported complaint could be due to dislodged x ray dot.This could have been caused by corrosion.Corrosion when it arises, only arises after long term exposure to csf.The valve was revised 2005.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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