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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Rupture (2208)
Event Type  Injury  
Manufacturer Narrative
The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Ting, w. , richard, s. A. , changwei, z. , chaohua, w. , <(>&<)> xiaodong, x. (2019). Concomitant occurrence of clinoid and cavernous segment aneurysms complicated with carotid cavernous fistula. Medicine, 98(48). Doi: 10. 1097/md. 0000000000018184. Medtronic literature review found a report of aneurysm rupture after pipeline implantation. A patient was admitted due to history of double vision. Magnetic resonance imaging (mri) and computer tomography (ct)-scan revealed dual aneurysms on the ica: a small clinoid segment aneurysm and a large cavernous segment aneurysm on the right ica. A 4. 5 mmx35mm pipeline was successfully inserted across the necks of the 2 aneurysms without complications. The post-procedure angiogram showed obvious contrast retention in the large aneurysm sac, while no contrast was seen in the small. Also, postprocedure ct revealed excellent apposition of the stent. Five days post-procedure, the patient was discharged home. Ten days after discharge from the hospital, the patient was readmitted because of proptosis and conjunctival congestion. A repeated cerebral angiography revealed carotid cavernous fistula (ccf) triggered by delayed cavernous carotid aneurysm rupture. The patient underwent embolization of the ccf. Three months follow-up with dsa revealed occlusion of the ccf. Two years follow reveal no further complications and the patient is well.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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 Key9918821
MDR Text Key195277946
Report Number2029214-2020-00323
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
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 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 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: 04/02/2020 Patient Sequence Number: 1
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