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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 Problems Positioning Failure (1158); Activation, Positioning or SeparationProblem (2906); Unintended Movement (3026); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2019
Event Type  malfunction  
Manufacturer Narrative
See related regulatory reports 2029214-2020-01312 and 2029214-2020-01313. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Cherian, j. , srinivasan, v. , froehler, m. T. , grossberg, j. A. , cawley, c. M. , hanel, r. A. , puri, a. , dumont, t. , ducruet, a. F. , albuquerque, f. , arthur, a. , cheema, a. , spiotta, a. , anadani, m. , lopes, d. , saied, a. , kim, l. , kelly, c. M. , chen, p. R. , <(>&<)> mocco, j. (2020). Flow diversion for treatment of intracranial aneurysms in pediatric patients: multicenter case series. Neurosurgery, 87(1), 53¿62. Doi:10. 1093/neuros/nyz380 medtronic received a literature article aiming to report technical, angiographic, and clinical outcomes in patients aged 21 or below undergoing flow-diversion treatment for intracranial aneurysms. The article included 39 patients undergoing 46 treatment sessions with pipeline embolization device placement between 2012 and 2018. A total of 50 intracranial aneurysms were treated. The study included a majority male patients. Nonsaccular morphology was seen in half of identified aneurysms. Six aneurysms were giant, and five patients were treated acutely after ruptured presentation. Complete aneurysm occlusion was seen in 74% of treated aneurysms. There was one case of device prolapse into the aneurysm, 2 cases of device placement too distal from target, and 2 cases of devices being too long. In all 5 of these cases, placement issues were corrected with either device replacement, device redeployment, or additional device placement. In 2 cases, failure of the flow diverter to open across a stenotic region of the parent artery necessitated use of a balloon-mounted stent to buttress open the flow diverter.
 
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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 Key11017176
MDR Text Key223462472
Report Number2029214-2020-01314
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
Report Date 12/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
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 Received11/16/2020
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

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