Catalog Number M00334530440 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Visual Disturbances (2140)
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Event Date 02/19/2016 |
Event Type
Injury
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Manufacturer Narrative
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This is 1 of 2 reports filed for two coils implanted.The subject device remains implanted.
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Event Description
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The patient underwent successful stent assisted coil embolization of an un-ruptured aneurysm located in the right fetal posterior cerebral artery origin.Post procedure the patient was assessed having a mrs of 1.It was reported that approximately 16 days post the index procedure the patient experienced right eye blurred vision (diplopia).No treatment was administered as examination in clinic was unremarkable.Neuro-imaging was stable; no changes in aneurysm and evidence of cerebrovascular accident.The study facility reported that the blurred vision was possibly related to the procedure and implanted coils.At 2, 6 and 12 months follow up, the patient had a nihss of 0 and a mrs of 1.The blurred vision resolved without treatment and there was no residual effect.No further information is available.
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Manufacturer Narrative
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The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.However, neurological/intracranial sequelae is a known risks associated with endovascular procedures and is noted as such in the device direction for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
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Event Description
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The patient underwent successful stent assisted coil embolization of an un-ruptured aneurysm located in the right fetal posterior cerebral artery origin.Post procedure the patient was assessed having a mrs of 1.It was reported that approximately 16 days post the index procedure the patient experienced right eye blurred vision (diplopia).No treatment was administered as examination in clinic was unremarkable.Neuro-imaging was stable; no changes in aneurysm and evidence of cerebrovascular accident.The study facility reported that the blurred vision was possibly related to the procedure and implanted coils.At 2, 6 and 12 months follow up, the patient had a nihss of 0 and a mrs of 1.The blurred vision resolved without treatment and there was no residual effect.No further information is available.
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Search Alerts/Recalls
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