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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
Model Number NV UNK FLEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Transient Ischemic Attack (2109); Obstruction/Occlusion (2422); Swelling/ Edema (4577)
Event Date 06/27/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Trivelato, f. P. , wajnberg, e. , rezende, m. T. S. , ulhoa, a. C. , piske, r. L. , abud, t. G. , castro-afonso, l. H. De, abath, c. G. C. , nakiri, g. S. , araujo, j. F. S. , silva, j. L. J. , tosello, r. T. , vanzin, j. R. , manzato, l. B. , baccin, c. E. , mota, b. A. A. Da, & abud, d. G. (2020). Safety and effectiveness of the pipeline flex embolization device with shield technology for the treatment of intracranial aneurysms: midterm results from a multicenter study. Neurosurgery, 87(1), 104-111. Medtronic received a literature article aiming to evaluate the outcomes of patients harboring aneurysms treated with the pipeline shield device. 151 patients with 182 aneurysms were enrolled between november 2017 and december 2018. The mean aneurysm size was 7. 0 mm; 27 aneurysms were large, and 7 were giant. Most aneurysms involved the paraophthalmic segment of the internal carotid artery, followed by the cavernous segment. One-hundred seventy aneurysms were located in anterior circulation. There were 169 saccular aneurysms. A branch arising from the sac was observed in 29 aneurysms. The study involved a majority female participants of an average age 53 years. In 141 of 151 patients, the primary endpoint was reached. The overall rate of periprocedural complications was 7. 3%. Of the aneurysms, 79. 7% met the study's secondary endpoint of complete occlusion at 6 month follow up and 85. 3% at 12 month follow up. In the study 9 patients experienced 3 minor strokes, 2 disabling ischemic strokes, 1 transient ischemic attack, 1 hemorrhage, 1 increase of mass effect, and 1 retinal ischemia were observed at follow-up. Four dissections of cervical vessels, 3 thromboembolic complications, and 2 vessel perforations, and 2 cases of in stent thrombosis were also observed. At the 6-mo follow-up, angiography revealed 2 cases of parent vessel occlusion and 3 cases of in-stent stenosis. No symptoms related to the stenosis/occlusion of the parent vessel were observed. All patients harboring ruptured aneurysms had an uneventful recovery.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key11016763
MDR Text Key225566465
Report Number2029214-2020-01309
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK FLEX
Device Catalogue NumberNV UNK FLEX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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

Patient Treatment Data
Date Received: 12/16/2020 Patient Sequence Number: 1
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