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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 FA-77450-16
Device Problem Migration (4003)
Patient Problem Aneurysm (1708)
Event Date 09/28/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Takong, w. , & kobkitsuksakul, c. (2020). Delayed proximal flow diverting stent migration in a ruptured intracranial aneurysm: a case report.   neurointervention,  15(3), 154¿157. Https://doi. Org/10. 5469/neuroint. 2020. 00220. Medtronic received a literature article pertaining to a 38 year old man who presented with a headache. Ct and ct angiography scans of the brain showed acute subarachnoid hemorrhage at the basal cistern and left sylvian fissure, as well as a possible tiny aneurysm at the left supraclinoid internal carotid artery. Cerebral angiogram showed a small blister aneurysm at the medial aspect of the left supraclinoid internal carotid artery, with a width of 1. 4mm and a neck of 1. 3mm. Endovascular treatment using a pipeline was performed to cover the supraclinoid aneurysm due to challenges in clipping and coiling. Before it was reported that there was braid foreshortening during stent deployment. At that time, the largest available suitable flow diverter as well as an unsheathing and pushing technique to minimize the ¿accordion¿ effect was performed. However, the stent still covered the aneurysm neck, with the distal end of the stent located at 3 mm distal to the neck, which demonstrated contrast stagnation within the aneurysm during contrast injection. No postoperative complications occurred, and the patient was doing well. However, four weeks later, follow up ct angiography of the brain showed proximal stent migration. There was only 50% aneurysmal neck coverage. A slightly increased size of the aneurysm was detected as well. Two weeks later, repeated cerebral angiograms demonstrated further increased size of the aneurysm to 5. 3mm wide and 5. 1 mm height with a narrowing aneurysmal neck of 2. 2 mm. Further foreshortening of the stent from 22. 1mm to 19. 8 mm in length was also. Intrasaccular coiling was then performed to resolve the issue and the procedure went well with the patient uneventfully discharged.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10999766
MDR Text Key222283336
Report Number2029214-2020-01294
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFA-77450-16
Device Catalogue NumberFA-77450-16
Device Lot NumberUNKNOWN
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 Received11/14/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/13/2020 Patient Sequence Number: 1
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