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Model Number MV-L401721 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intimal Dissection (1333); Death (1802); Hemorrhage, Cerebral (1889)
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Event Date 02/10/2020 |
Event Type
Death
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Manufacturer Narrative
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A search for non-conformance associated with the part/lot number combination of the device could not be conducted as the lot number was not provided.The lvis stent was implanted and the delivery system was not returned for evaluation.The instructions for use identifies perforation or dissection of vessels, hemorrhaging, stroke, and death as potential complications associated with use of the device.This device was used during the same procedure as the device referenced in mfr.Report # 2032493-2020-00033.
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Event Description
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It was reported that treatment was performed for an unruptured right p-com aneurysm.After uneventful placement of the web, imaging demonstrated a small amount of encroachment of the parent artery [right internal carotid artery (rica)]; however, there was good flow within the rica and decreased flow into the aneurysm sac.The web was detached approximately 7 minutes after deployment.A neuro check was performed at the end of the procedure and the patient exhibited weakness of the left upper extremity and signs of a stroke.Immediate 3-d imaging demonstrated reduced flow in the rica and web migration from the aneurysm sac into the distal right mca-m1 segment.There was total occlusion of the right mca branches and outflow.Multiple attempts were made with a stentriever to remove the web; however, they were unsuccessful.The lvis stent was implanted to compress the web against the m1 vessel wall, followed by multiple (non-microvention) balloon inflations; however, there was only slight increase in flow into the outflow territory.The m1 segment appeared to have a new vessel dissection with associated extravasation.Ten (10) embolization coils were implanted in the parent vessel to stop the extravasation.Final angiogram demonstrated total occlusion of the mca vessel and outflow.The patient was intubated and transferred to the neuro-icu.It was reported that the patient died on (b)(6) 2020 after being removed from life support.The cause of the patient's death was determined to be "pressure build-up pushing down on the brainstem, secondary to hemorrhagic stroke.".
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Search Alerts/Recalls
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