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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 Intracranial Hemorrhage (1891); Thromboembolism (2654)
Event Date 06/01/2020
Event Type  Injury  
Manufacturer Narrative
Neyens r, donaldson c, andrews c, kellogg r, spiotta a. , platelet function testing with a verifynow-directed personalized antiplatelet strategy and associated rates of thromboembolic complications after pipeline embolization for complex cerebral aneurysms, world n eurosurgery, volume 138, 2020, pages e674-e682, issn 1878-8750, https://doi. Org/10. 1016/j. Wneu. 2020. 03. 046. 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. This value is the average weight 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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Neyens r, donaldson c, andrews c, kellogg r, spiotta a. , platelet function testing with a verifynow-directed personalized antiplatelet strategy and associated rates of thromboembolic complications after pipeline embolization for complex cerebral aneurysms, world n eurosurgery, volume 138, 2020, pages e674-e682, issn 1878-8750, https://doi. Org/10. 1016/j. Wneu. 2020. 03. 046. The purpose of this article was evaluate thrombotic complications between patients who received verifynow-directed personalized anti platelet therapy versus those who did not after pipeline embolization device (ped) flow diversion of complex cerebral aneurysms. The authors reviewed 269 cases of patients undergoing implantation of a ped for complex aneurysm treatment. Of the 269 patients, the average age was 57 years, 209 were female and 60 were male. The article does not state any technical issues during use of the ped. All thrombotic and hemorrhagic complications were included if they occurred at any period during the ped procedure and for 6 months after the ped procedure. All complications were identified by a combination of clinical symptoms and radiographic findings including computed tomography, computed tomography angiography, magnetic resonance imaging (mri), or digital subtraction angiography. The following intra- or post-procedural outcomes were noted: 17 patients experienced thrombotic complications, 10 patients experienced hemorrhagic complications post-procedure, and the majority were symptomatic. All thrombotic complications occurred in patients who were changed to ticagrelor versus those who were maintained on clopidogrel, and all hemorrhages occurred in patients taking clopidogrel. Most of the thrombotic complications (57. 9%) occurred either during the intraoperative or immediate postoperative period. Most hemorrhagic complications occurred beyond the initial perioperative period (60%).
 
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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 Key10975759
MDR Text Key220659761
Report Number2029214-2020-01263
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
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 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
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: 12/09/2020 Patient Sequence Number: 1
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