As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: argyriou, c., schoretsanitis, n., kantartzi, k., panagoutsos, s., souftas, v.D., lazarides, m.K., & georgiadis, g.S.(2019).Use of a temporary shunt to preserve the patency of a hemodialysis graft while performing ipsilateral axillo-femoral bypass.The journal of vascular access, 20(5), 553¿556.Doi: 10.1177/1129729818820205.
|
It was reported in an article from the journal of vascular access titled " use of a temporary shunt to preserve the patency of a hemodialysis graft while performing ipsilateral axillo-femoral bypass " that a carotid shunt was placed in a patient with a-v graft preserving continuous ipsilateral upper arm access flow when constructing a unilateral axillo-femoral polytetrafluoroethylene bypass operation for critical limb ischemia in a hemodialysis patient.However, ultrasound imaging revealed a decrease in blood flow through the graft, probably representing a physiologic steal syndrome without clinical presentation of worsening arm ischemia.The patient was discharged home the fourth post-operative day with a patent access graft.The a-v graft continued to be used as a vascular access until 4 months later when it became thrombosed.The status of the patient was not provided.
|
It was reported in an article from the journal of vascular access titled " use of a temporary shunt to preserve the patency of a hemodialysis graft while performing ipsilateral axillo-femoral bypass " that a carotid shunt was placed in a patient with a-v graft preserving continuous ipsilateral upper arm access flow when constructing a unilateral axillo-femoral polytetrafluoroethylene bypass operation for critical limb ischemia in a hemodialysis patient.However, ultrasound imaging revealed a decrease in blood flow through the graft, probably representing a physiologic steal syndrome without clinical presentation of worsening arm ischemia.The patient was discharged home the fourth post-operative day with a patent access graft.The a-v graft continued to be used as a vascular access until 4 months later when it became thrombosed.The status of the patient was not provided.
|