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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EV3 AXIUM 3D
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EV3 AXIUM 3D Back to Search Results
Lot Number 9797457
Device Problem Coiled (1098)
Patient Problems Aneurysm (1708); Infarction, Cerebral (1771); Edema (1820); Weakness (2145); Rupture (2208)
Event Date 11/27/2013
Event Type  Injury  
Event Description
This pt was enrolled on the (b)(6), a multi-center prospective aneurysm clinical trial, and was randomized to the bare platinum treatment arm.The pt is a (b)(6) female who presented with an ruptured aneurysm on the right middle cerebral artery (mi).The aneurysm was coiled on (b)(6) 2013, the pt developed a sudden onset of transient left-sided weakness prior to discharge.Ct/cta was done and showed mild/moderate vasospasm, improvement in edema, and late subacute infarction in the right corona radiata extending to the right middle frontal gyrus.The pt was treated with nimodipine, statin, aspirin, sodium monitoring, and bp monitoring.The pt is now improving and was discharged on (b)(6) 2013.The transient left-sided weakness was reported as serious adverse event which resulted in permanent of a body structure or a body function and required "in subject" hospitalization or prolongation of existing hospitalization.
 
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Brand Name
AXIUM 3D
Type of Device
AXIUM 3D
Manufacturer (Section D)
EV3
MDR Report Key3759612
MDR Text Key4553131
Report NumberMW5035678
Device Sequence Number1
Product Code HCG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 04/14/2014
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date09/01/2016
Device Lot Number9797457
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/15/2014
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age59 YR
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