Catalog Number M0031681890 |
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 06/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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This is 11 of 12 emdr filed for this event (10 coils and 2 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 of the un-ruptured aneurysm, the patient experienced headache which resolved without residual effect the next day.Post procedure the patient was assessed having a mrs of 0 and the aneurysm occlusion status was assessed as 2 - residual neck/dog ear defined as the persistence of any portion of the original defect of the arterial wall.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 patient follow up visits at 2 and 6 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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The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.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 of the un-ruptured aneurysm, the patient experienced headache which resolved without residual effect the next day.Post procedure the patient was assessed having a mrs of 0 and the aneurysm occlusion status was assessed as 2 - residual neck/dog ear defined as the persistence of any portion of the original defect of the arterial wall.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 patient follow up visits at 2 and 6 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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