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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Ischemia (1942)
Event Date 02/05/2020
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
Kumar, a. , dmytriw, a. A. , salem, m. M. , kuhn, a. L. , phan, k. , bharatha, a. , ¿ marotta, t. R. (2020). Reconstructive vs deconstructive endovascular approach to intradural vertebral artery aneurysms: a multicenter cohort study. Neurosurgery. Doi: 10. 1093/neuros/nyaa005. Medtronic literature review found reports of patient complications after pipeline placement. The purpose of this article was to compare the long term clinical outcomes of intradural vertebral artery aneurysms after parent vessel sacrifice vs. Flow diverter (pipeline. ) the authors reviewed the results of 31 of the patients underwent pipeline placement to treat vertebral artery aneurysms. The average age was 53 years; 17 of the patients were female. The article notes the following complications: - 6 postoperative ischemic complications - 2 postoperative hemorrhagic complications.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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 Key9926143
MDR Text Key195547299
Report Number2029214-2020-00327
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P100018.S011
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 04/04/2020
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
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 Received03/10/2020
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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