Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ischemia (1942); Neurological Deficit/Dysfunction (1982)
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Event Date 01/20/2015 |
Event Type
Injury
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Manufacturer Narrative
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Citation: francesco briganti, luigi delehaye, giuseppe leone, et al."flow diverter device for the treatment of small middle cerebral artery aneurysms." j neurointervent surg 2016;8:287¿294.The devices involved in the event will not be returned for evaluation as they were implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patients post procedure and its cause was unknown.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information through review of literature that post pipeline treatment, four patients experienced ischemic complications with 3 permanent neurological deficits.Complete occlusion was obtained in 12/15 aneurysms (80%) and partial occlusion in 3 (20%).Among 13 aneurysms with a side branch, they were patent at the angiographic control in 4 cases, showed decreased filling in 6, and was occluded in 3 (with neurological deficits in 2).All peds were patent at follow-up.Post-procedural ischemic complications occurred in 4 (27%) patients with permanent neurological deficit (modified rankin score 2) in 3 patients (21%).
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Manufacturer Narrative
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Patient information added to section.
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Event Description
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In this study a total of 14 patients were treated (10 women; mean age 59 years).
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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