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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 Stroke/CVA (1770); Intracranial Hemorrhage (1891); Thromboembolism (2654)
Event Date 07/06/2020
Event Type  Injury  
Manufacturer Narrative
The patient age provided in this report is representative of the median age for all patients included in the study literature. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Griessenauer, c. J. , enriquez-marulanda, a. , taussky, p. , biswas, a. , grandhi, r. , xiang, s. , hong, t. , rinaldo, l. , lanzino, g. , brinjikji, w. , burkhardt, j. , kan, p. , ghuman, m. , yang, v. X. D. , chen, k. , aziz-sultan, m. A. , ghorbani, m. , schirmer, c. M. , goren, o. , dalal, s. S. , killer-oberpfalzer, m. , muller-thies-broussalis, e. , koch, m. J. , stapleton, c. J. , patel, a. B. , foreman, p. M. , cress, m. C. , hirschl, r. A. , krings, t. , zhang, h. , dmytriw, a. A. (2020). Experience with the pipeline embolization device for posterior circulations aneurysms: a multicenter cohort study. Neurosurgery, 87(6), 1252-1261. Abstract background: the pipeline embolization device (ped; medtronic) has been used off label for the treatment of challenging posterior circulation aneurysms. Data on this modality are primarily limited to small retrospective single-center series. Objective: to assess safety and efficacy of this treatment by establishing an international, multicenter collaboration. Methods: consecutive posterior circulation aneurysms treated with the ped from 2012 to 2019 across 11 neurovascular centers were ret rospectively reviewed. Baseline demographics, aneurysm and treatment characteristics, complications, occlusion status, and functional outcome were assessed. Results: there were 149 posterior circulation aneurysms treated with ped in 146 patients. A total of 24 (16. 4%) patients presented with subarachnoid hemorrhage. Most aneurysms were dissecting/blister (36. 2%) in morphology, followed by saccular (35. 6%) and fusiform (28. 2%). The most common locations were the vertebral (51. 7%) and basilar arteries (22. 8%). Complete or near-complete occlusion (>90%) was achieved in 90. 9% of aneurysms at a median follow-up of 12 mo. Dissecting/blister aneurysms were most likely to occlude (p
=
. 06). Symptomatic neurologic complications occurred in 9. 4% of aneurysms, associated with larger size, ruptured presentation, presentations with brain stem compression, cranial nerve palsy, or stroke. Favorable functional outcome (modified rankin score 0-2) was achieved in 86. 2% of patients. There were 6 fatalities of which 4 occurred in aneurysmal subarachnoid hemorrhage patients. Conclusion: this multicenter study shows that ped for the treatment of posterior circulation is preferentially used for the treatment of fusiform and dissecting/blister aneurysm morphologies. Despite the challenges presented by these less-common morphologies, flow diversion may be performed with a neurologic complication rate of about 10% and favorable long-term aneurysm occlusion rates. 14 patients included included the study experienced serious adverse events/injuries post-operatively. Of these 14 patients, 11 experienced symptomatic thromboembolic ischemic stroke, 3 experienced symptomatic hemorrhage. Of the three patients that experienced symptomatic hemorrhage, 2 patients had intraparenchymal hemorrhage and 1 patient had subarachnoid hemorrhage.
 
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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 Key10949831
MDR Text Key221229451
Report Number2029214-2020-01234
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 literature
Reporter Occupation
Type of Report Initial
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
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-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 Received11/13/2020
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: 12/04/2020 Patient Sequence Number: 1
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