On an unknown date, around 2018 - 2019, 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 late 2019, follow-up echo examination showed graft delamination.Graft occlusion was also confirmed at the same site.On an unknown date, pta ballooning was performed to treat the delamination and occlusion.On an unknown date, the graft occlusion and the graft delamination were confirmed again at the same site.On an unknown date, pta ballooning was performed to treat the delamination and occlusion.The graft remains implanted and the patient is being monitored.The physician reportedly commented it was not determined if the graft delamination occurred at the puncture site or not.The cause of the occlusion is unknown.
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Engineering evaluation task was performed and the results are: 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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