On an unknown date, in 2018, the patient was implanted with a gore® acuseal vascular graft as an av shunt for hemodialysis on the left forearm.On an unknown date in (b)(6) 2020, a follow-up echo examination showed possibility of the graft delamination.As a treatment, ballooning was performed.The graft remains implanted and the patient is being monitored.The physician reported the inner layer of eptfe appears to have peeled off of the silicon.The physician reportedly suspects cause of the delaminiation may be needle puncture.
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H6: code 4114 - refer to the device evaluation summary below for the results of the engineering evaluation.The identity of the device was not provided; therefore, the device history record could not be examined to identify any potential root causes attributable to the manufacture of the device.The event description could not be confirmed, as no identity or image of the device was provided for evaluation.
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