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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 Hemorrhage/Bleeding (1888); Thromboembolism (2654)
Event Date 07/01/2020
Event Type  Injury  
Manufacturer Narrative
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 as the event dates were not provided in the published literature. Griessenauer cj, enriquez-marulanda a, xiang s, et al. Comparison of ped and fred flow diverters for posterior circulation aneurysms: a propensity score matched cohort study. Journal of neurointerventional surgery published online first: 01 july 2020. Doi: 10. 1136/neurintsurg-2020-016055. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Griessenauer cj, enriquez-marulanda a, xiang s, et al. Comparison of ped and fred flow diverters for posterior circulation aneurysms: a propensity score matched cohort study. Journal of neurointerventional surgery published online first: 01 july 2020. Doi: 10. 11 36/neurintsurg-2020-016055. Medtronic literature review found reports of patient complications in association with pipeline implantation for treatment of aneurysms of the posterior circulation. The purpose of the article was to perform a propensity score matched cohort study comparing the pipeline embolization device (ped) and flow redirection intraluminal device (fred) for posterior circulation aneurysms. The authors reviewed a total of 375 treated aneurysms in 369 patients. The pipeline was used in 285 patients. Of the 285 patients, the average age was 57 years, and 147 female. The article does not state any technical issues during the use of the pipeline. In addition, 242 patients had an mrs score of less than or equal to 2 on the last follow-up. The following intra- or post-procedural outcomes were noted: 37 patients experienced thromboembolic complications per procedure. 14 patients experienced hemorrhagic complications per procedure.
 
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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 Key10319646
MDR Text Key203699879
Report Number2029214-2020-00720
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
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 Received07/06/2020
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: 07/24/2020 Patient Sequence Number: 1
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