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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 Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Optical Nerve Damage (1986); Therapeutic Effects, Unexpected (2099); Device Embedded In Tissue or Plaque (3165)
Event Date 11/01/2011
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Kole mj, miller tr, cannarsa g, et al. Pipeline embolization device diameter is an important factor determining the efficacy of flow diversion treatment of small intracranial saccular aneurysms. Journal of neurointerventional surgery. 2019;11(10):1004-1008. Doi:10. 1136/neurintsurg-2019-014792. Medtronic received a report from a clinical study through a literature article to investigate whether pipeline diameter influences treatment efficacy when using a single device. In this study there were 224 intrasaccular aneurysms in 185 patients were treated from nov 2011 to oct 2016. All aneurysms were in the anterior circulation, most form the internal carotid artery at or proximal to the posterior communicating artery origin. The average aneurysm size was 4. 8mm. In this study 123 aneurysms were occluded over an average follow up of 26. 6 months. Complications occurred including 6 instances of procedure-related morbidity. 1 patient had bilateral punctate embolic infarctions following treatment, 1 developed what appeared to be foreign body granulomas throughout the ipsilateral cerebral hemisphere following pipeline placement. Both complications resolved without permanent neurological morbidity, but the second patient is maintained on corticosteroid therapy. 1 patient experienced an ipsilateral occipital intraparenchymal hemorrhage post-procedure, resulting in a permanent quandrantanopsia. 2 patients developed retroperitoneal hematomas that were treated conservatively, and a third patient developed a femoral artery pseudoaneurysm at the insertion site which was treated with percutaneous thrombin injection.
 
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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 Key9238981
MDR Text Key173445816
Report Number2029214-2019-01080
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 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2019
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-RPT
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 Received09/25/2019
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: 10/25/2019 Patient Sequence Number: 1
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