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Model Number W4-7-4-MVI-3 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Hematoma (1884); Vomiting (2144); Obstruction/Occlusion (2422); Confusion/ Disorientation (2553); Thrombosis/Thrombus (4440)
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Event Date 01/14/2021 |
Event Type
Injury
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Manufacturer Narrative
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A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and was not returned to the manufacturer for evaluation.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies neurological deficits, parent artery occlusion, thromboemboli, and ischemic stroke as potential complications associated with use of the device.
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Event Description
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It was reported that an unruptured anterior communicating artery (aca) aneurysm was treated with a web device.The device was implanted with no issues, and control angiograms showed no flow delay in the either aca.An anterior frontal m3 branch was then found to be occluded.Intra-arterial tpa 4mg was administered and a stent retriever were used, and recanalization was achieved.The patient had not been heparinized for 20 minutes during implantation of the device as the act machine was broken and a new one had to be retrieved.7 hours post-procedure, the patient vomited and was confused.A ct showed a left frontal hematoma, caused by the ia tpa and microwire manipulation, and also indication of bilateral distal aca stroke.It is the physician's opinion that the clot in the m3 was most likely not associated with the web device, but the that the bilateral aca strokes were most likely caused by micro-emboli from the proximal surface of the device.It was related that the patient is now in a long term acute care facility and has "resumed modified oral diet and has started saying a few words.Still is dependent on nursing care for activities of daily living.".
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Search Alerts/Recalls
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