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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Hemorrhage, Subarachnoid (1893); Paresis (1998); Perforation of Vessels (2135)
Event Date 02/19/2020
Event Type  Injury  
Manufacturer Narrative
Citation: virtual simulation with sim size software for pipeline flex embolization: evaluation of the technical and clinical impact lorenzo piergallini ,1,2 federico cagnazzo et. Al. The pipeline flex devices will not be returned for evaluation; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information through literature review. In our experience, the use of the virtual simulation during pipeline treatment significantly reduced the need for corrective intervention, the procedural time, the radiation dose, and the length of the stent. In the univariate analysis, compared with interventions without sim size use, procedures with the software had a lower rate of need for corrective intervention (9% vs 20%, p
=
0. 036). Overall, in the group without simulation, five patients (5%) experienced complications: one small intraparenchymal hematoma due to a perforator artery rupture, likely caused by the guidewire of the stent; two minor strokes (diffusion-positive spot in the lenticular and corona radiata, respectively) with light motor symptoms completely regressed; one modest subarachnoid hemorrhageafter procedure likely due to the arterial stretching; and one small intraparenchymal hematoma together with modest subarachnoid hemorrhage, likely due to perforator artery rupture. In the group with simulation, three patients (3%)experienced complications: one embolic partial occlusion of the right central sulcus (rolandic) artery with hemiparesis that partially resolved; one minor stroke with a transient deficit of the leg; and one asymptomatic internal carotid artery dissection. All complications but one (the embolic central artery partial occlusion in the simulation group, in which leg weakness persisted after discharge) fully resolved without sequelae.
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9929148
MDR Text Key189090537
Report Number2029214-2020-00338
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 04/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberNOT REPORTED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/10/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/06/2020 Patient Sequence Number: 1
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