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Catalog Number M0031681920 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Headache (1880)
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Event Date 04/22/2016 |
Event Type
Injury
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Manufacturer Narrative
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This is 10 of 12 emdr reports filed for this event (9 coils and 3 microcatheters).The subject device is not available.
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Event Description
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It was reported that during the stent assisted coil embolization procedure, the patient experienced headache which resolved without residual effect the next day.Post procedure the patient was assessed having a mrs of 0.Also, the aneurysm occlusion status post procedure was assessed as complete obliteration, no opacification of the aneurysm or neck, (leaving neck to preserve branch is considered modified class i).The study facility assessed the headache as being possibly related to the stent and procedure; however, unknown to the implanted coils and microcatheters (subject device).During follow up visits at 2, 6, and 12 months post the index procedure, the patient was assessed having a mrs of 0.No further information is available.
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Manufacturer Narrative
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A review of the device history record could not be performed because the lot number was not reported and it could not be obtained.The subject device is not available; therefore, physical as well as a functional evaluation could not be performed.However, headache is a known complication noted in the clinical experience summary for neurovascular microcatheters.Therefore, an assignable cause of anticipated procedural complications was assigned to this event.
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Event Description
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It was reported that during the stent assisted coil embolization procedure, the patient experienced headache which resolved without residual effect the next day.Post procedure the patient was assessed having a mrs of 0.Also, the aneurysm occlusion status post procedure was assessed as complete obliteration, no opacification of the aneurysm or neck, (leaving neck to preserve branch is considered modified class i).The study facility assessed the headache as being possibly related to the stent and procedure; however, unknown to the implanted coils and microcatheters (subject device).During follow up visits at 2, 6, and 12 months post the index procedure, the patient was assessed having a mrs of 0.No further information is available.
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Search Alerts/Recalls
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