An evaluation of the actual complaint sample could not be performed as the device was implanted and reported unavailable.The physician noted that there were no complications deploying the coils during the procedure.However, it was also noted that the physician would bring the patient back at a later time to insert a pipeline, thus implying the neck of aneurysm was wide.On (b)(6) 2018, a cta follow up was done showing the coils still intact.On (b)(6) 2018 the patient had a stroke and the md suspected was the result of a significant amount of the proximal coil being displaced into the parent artery.Coil prolapse into the parent artery is a well-characterized complication of endovascular treatment.Coils that protrude into the parent vessel after deployment can be carried into distal vessels with the potential to create a thrombogenic mass.Based on studies reporting large series of patients, coil prolapse (also called protrusion, herniation, or displacement) occurs in up to 4.5% (112/2497) of patients treated with any coil device.Coil prolapse may result from a variety of causes, including size mismatch between the coils and aneurysm, inadequate position of the microcatheter, coil instability after detachment, excessive embolization, microcatheter or stent related problems, or from being pushed by subsequent coil embolization.Prolapse occurred in aneurysms with wide or "loose" necks in 15 studies.Thus, the cause is typically not associated with the coil itself, but rather due to procedural or operator-related complications, including placement of multiple coils, which has the potential to displace one or more coils into the parent artery.Root cause in this case is believed to be an inherent procedural complication, notably due to the reported wide neck of the treatment site.Lack of immediate support in the form of a pipeline further increased the risk of proximal coil displacement into the parent artery.Lack of device return prevented deeper evaluation of the reported issue.
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