Model Number FA-77375-14 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Encephalopathy (1833); Neurological Deficit/Dysfunction (1982)
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Event Date 12/18/2014 |
Event Type
Injury
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Event Description
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Treatment of a small aneurysm measuring approximately 7mm located in the para-ophthalmic segment of the ica (internal carotid artery).The patient was given plavix and aspirin.The patient's baseline status was stable prior to the procedure.On (b)(6) 2014, the patient underwent pipeline embolization treatment.Mri (magnetic resonance imaging) post procedure suggested vasculopathy or posterior reversible encephalopathy syndrome.Mostly ipsilateral cerebral hemisphere.The relation to the adverse event may be that there was poor wall apposition proximally.The patient exhibited weak strength in the left arm and hand in relation to the reported adverse event.Medication was provided for the ae (specific name were not reported).The patient's current medical condition is good, 4 out of 5 returned strength.This institution does not test pru levels.No further complications were reported as a result of the procedure.
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Manufacturer Narrative
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The lot history record reivew was not possible since the lot number was not reported.The device involved in the event will not be returned for evaluation as it was implanted in the patient.(b)(4).
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Manufacturer Narrative
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Attempts to obtain the lot number of the ped were made, however the site was not be able to provide the lot number of the device.(b)(4).
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Event Description
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Subsequent to the initial mdr, medtronic (covidien) received new information regarding the patient's medical history.The patient had a rupture of right posterior communicating aneurysm 6 months prior to the pipeline embolization device (ped) placement.Follow up angiography showed that the aneurysm regrow with wide neck and it failed balloon assisted re-coilling.Post ped placement procedure, the patient developed severe headache that was refractory to steroids within a few hours.Three days post procedure, the patient presented to the emergency room with left hemiparesis and the magnetic resonance imaging (mri) showed presumed patchy edema in the right cerebral hemisphere.One month post procedure, the patient showed clinical improvement although not fully intact yet.
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Search Alerts/Recalls
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