Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Occlusion (1984); Stenosis (2263); Therapeutic Response, Decreased (2271); Thromboembolism (2654)
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Event Type
Injury
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Manufacturer Narrative
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Moshayedi h, omofoye oa, yap e, oyekunle to, sasaki-adams dm, solander sy, factors affecting the obliteration rate of intracranial aneurysms treated with a single pipeline embolization device, world neurosurgery (2017), doi: 10.1016/j.Wneu.2017.04.111.The pipeline devices will not be returned for evaluation as they remain implanted in the patients.Product analysis will not be performed.The events do not appear to be related to any defect of the pipeline devices.The information provided in the article is not enough to conclusively determine the cause of the patients' procedural and post-procedural complications.
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Event Description
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Medtronic literature review found reports of embolic stroke, artery occlusion, and retreatment after pipeline implantation.The purpose of this study was the analyze the outcomes of intracranial aneurysm treatment using a single pipeline embolization device (ped).The authors wanted to specifically evaluate the factors affecting aneurysm obliteration rates.The authors retrospectively reviewed 47 patients who underwent treatment for 58 aneurysms.All patients were treated using a single ped.Forty two of the patients were female and the mean age was 52.8 years.The article states that two patients experienced small embolic strokes during the procedure; the strokes were confirmed on mri.- the article states that one patient continued to have headaches and diplopia after the procedure, but was otherwise neurologically intact.The article states the patient¿s symptoms were likely unrelated to the embolic stroke.- the second patient developed left sided weakness, facial droop, and pronator drift after the procedure.Mri demonstrated a few tiny foci of restricted diffusion, but symptoms resolved completely a few days later at discharge.The article states that one patient experienced occlusion of the ophthalmic artery after ped implantation.The ped had been implanted to treat a cerebral aneurysm; the ophthalmic artery arose from the aneurysm neck.Follow-up angiography showed the aneurysm was completely obliterated; the angiogram also showed the ophthalmic artery (which arose from the aneurysm neck) was also occluded.The patient did not experience any visual symptoms despite ophthalmic artery occlusion.The article states that one patient underwent retreatment after ped implantation.The patient underwent ped implantation in the treatment of an aneurysm; the ophthalmic artery arose from the aneurysm neck.The patient¿s one-year post-procedure angiogram showed incomplete aneurysmal obliteration.After two years of incomplete aneurysm occlusion, a second ped was placed.The aneurysm remained patent on angiographic follow-up.
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Search Alerts/Recalls
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