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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Kang, h. , zhou, y. , luo, b. Et al. Pipeline embolization device for intracranial aneurysms in a large chinese cohort: complication risk factor analysis. Neurotherapeutics (2021). Doi. Org/10. 1007/s13311-020-00990-8 this value is the average age of the patients reported in the article as specific patients could not be identified. This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature. Refer to manufacturer report 2029214-2021-00825 for details pertaining to the related reportable event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Kang, h. , zhou, y. , luo, b. Et al. Pipeline embolization device for intracranial aneurysms in a large chinese cohort: complication risk factor analysis. Neurotherapeutics (2021). Doi. Org/10. 1007/s13311-020-00990-8 medtronic literature review found reported of patient complications in association with implantation of the classic or flex pipeline embolization device (ped) deployed through a marksman microcatheter. The purpose of this article was to assess real-world predictors of complications and functional outcomes in patients treated with the ped in a chinese population. The authors reviewed 1171 cases of patients treated for intracranial aneurysms using the ped. Of the 1171 patients, the average age was 53. 9 years, 813 were female. The following intra- or post-procedural outcomes were noted: major ischemic stroke (51 patients), delayed aneurysm rupture (dar) (24 patients), distal intraparenchymal hemorrhage (diph) (23 patients).
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12126010
MDR Text Key261690496
Report Number2029214-2021-00826
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 07/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
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 Received06/14/2021
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: 07/06/2021 Patient Sequence Number: 1
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