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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
Model Number NV UNK PIPELINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Ischemia (1942); Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109); Rupture (2208); Stenosis (2263)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
The pipeline devices have not been returned for evaluation; product analysis cannot be performed. The devices have not been returned; the reported events could not be confirmed. The causes of the events could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Sweid, a. , starke, r. M. , herial, n. , chalouhi, n. , das, s. , baldassari, m. P. , ¿ jabbour, p. (2019). Predictors of complications, functional outcome, and morbidity in a large cohort treated with flow diversion. Neurosurgery. Doi: 10. 1093/neuros/nyz508. Medtronic literature review found a report of patient complications after pipeline implantation. The purpose of this article was to assess the predictors of complications/morbidity in patients treated with the pipeline (ped). The authors reviewed the results of 509 patients; average age was 55 years, 84% were female. The article notes the following complications: - 17 patients with ischemic stroke - 8 tia/minor stroke - 7 delayed aneurysm rupture - 9 distal intraparenchymal hemorrhage - 6 asymptomatic hemorrhage - 34 in-stent stenosis - 6 delayed neurological sequelae.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9926161
MDR Text Key195547115
Report Number2029214-2020-00329
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,Followup
Report Date 05/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberNOT-REP
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 Received05/29/2020
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: 04/04/2020 Patient Sequence Number: 1
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