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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); Transient Ischemic Attack (2109); Thrombosis/Thrombus (4440)
Event Date 07/03/2020
Event Type  Injury  
Manufacturer Narrative
Pressman e, de la garza ca, chin f, et al. Nuisance bleeding complications in patients with cerebral aneurysm treated with pipeline embolization device journal of neurointerventional surgery published online first: 03 july 2020. Doi: 10. 1136/neurintsurg-2020-016245. Patient age: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Event date: 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
Pressman e, de la garza ca, chin f, et al. Nuisance bleeding complications in patients with cerebral aneurysm treated with pipeline embolization device journal of neurointerventional surgery published online first: 03 july 2020. Doi: 10. 1136/neurintsurg-2020-016245. Medtronic literature review found reported of patient complications in association with cerebral aneurysms treated with a pipeline embolization device (ped). The purpose of this article was evaluate the frequency and factors associated with nuisance bleeding and its effect on dual antiplatelet therapy (dapt) compliance. The authors reviewed 243 cases of patients: the average age was 56 years, 201 were female and 42 were male. The article does not state any technical issues during use of the ped. Alarming bleeding was defined as intracranial or life-threatening bleeding or that requiring blood transfusion. The following intra- or post-procedural outcomes were noted: 1. 15 alarming bleeding (most common was intracranial bleeding with six patients), out of the 67 patients, 14 had additional internal or alarming bleeding events - five required procedures for the bleeding, five had to have elective procedures postponed because of dual antiplatelet therapy (dapt), and 15 returned to the emergency department for bleeding-related complications, five patients suffered an ischemic complications after the withdrawal of their dapt. One suffered a transient ischemic attack (tia), one an acute stroke, and three in-stent thromboses.
 
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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 Key11009674
MDR Text Key221515583
Report Number2029214-2020-01304
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
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 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: 12/15/2020 Patient Sequence Number: 1
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