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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Muscle Weakness (1967); Therapeutic Response, Decreased (2271)
Event Date 03/14/2018
Event Type  Injury  
Manufacturer Narrative
The pipeline devices will not be returned for evaluation as they remain implanted in the patients. Based on the provided information, there does not appear to have been any defect of the devices during use. The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Wallace, a. N. , kamran, m. , madaelil, t. P. , kayan, y. , osbun, j. W. , roy, a. K. , grossberg, j. A. (2018). Endovascular treatment of posterior inferior cerebellar artery aneurysms with flow diversion.  world neurosurgery, 114. Doi:10. 1016/j. Wneu. 2018. 03. 036. Medtronic literature review found a report of patient complications after pipeline implantation. The purpose of this article was the examine the procedural, clinical, and angiographic outcomes of patients with posterior inferior cerebellar artery (pica) aneurysms treated with the pipeline embolization device (ped. ) the authors retrospectively reviewed the results of 14 patients treated with ped. Of the patients, 2 were male and 12 were female; mean age was 66. 2 years. The article describes the following post-procedure events: patient 10 ((b)(6), female) underwent ped placement in the treatment of a saccular, left pica aneurysm. Post-procedure, the patient developed a pica territory infarct with mild leg weakness that resolved in <7 days. Patient 1 ((b)(6), female) underwent ped placement in the treatment of a fusiform, left pica aneurysm. The article states the patient underwent retreatment 7 months post-procedure due to residual aneurysm. Patient 3 ((b)(6), female) underwent ped placement in the treatment of a dissecting vertebral artery aneurysm and fusiform, right pica aneurysm. Follow-up imaging 18 months post-procedure showed persistent filling of the pica aneurysm. The patient underwent retreatment.
 
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Brand NamePIPELINE 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
7635263305
MDR Report Key8781654
MDR Text Key150735220
Report Number2029214-2019-00728
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
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 Received06/17/2019
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: 07/11/2019 Patient Sequence Number: 1
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