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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); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 04/11/2021
Event Type  Injury  
Manufacturer Narrative
See manufacturer report # 2029214-2021-00805 for a related report from the article. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Lauzier dc, root bk, kayan y, et al. Pipeline embolization of proximal middle cerebral artery aneurysms: a multicenter cohort study. Interventional neuroradiology: journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences. May 2021:15910199211015578. Doi:10. 1177/15910199211015578 medtronic literature review found a report of patient complications in association with a pipeline device. The purpose of this article was to measure safety and efficacy for pipeline embolization in the proximal middle cerebral artery in a multi-center cohort. Of the 24 patients reviewed, 15 were female (60%), and the average age was 53. 7 years (range 16-72 years). The following intra- or post-procedural outcomes were noted: - one pipeline herniated into the aneurysm during the procedure. A second pipeline was deployed through the first device into aneurysm outflow tract. This did not result in clinical sequelae. - one patient experienced ischemic stroke secondary to pipeline thrombosis 4 months post-treatment. This patient was not treated with thrombolytic therapy and was discharged 2 days after presentation with a return to normal level of function (mrs 0). This patient¿s aneurysm was occluded at follow-up imaging. No additional complications occurred. The patient¿s aneurysm was located in the m1 segment. - one patient experienced ischemic stroke with thrombosis of pipeline two weekspost-procedure. Iv and ia abciximab administration restored patency of the ped, and the patient was discharged 5 days after initial stroke presentation with a return to baseline level of function (mrs 0). This patient¿s aneurysm was occluded at this time. No additional complications occurred. The patient¿s aneurysm was located in the m1 segment. - in-stent stenosis or occlusion was observed at 6-month and finial follow-up imaging for two patients. This comprised of one case of 10% stenosis and one case of complete pipeline occlusion. - two aneurysms were re-treated with a pipeline following initial pipeline treatment, with subsequent complete occlusion in one aneurysm and subsequent subtotal filling in the other. - three patients had clinically silent infarcts identified with cross-sectional imaging. The patients were asymptomatic.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12105213
MDR Text Key261689245
Report Number2029214-2021-00806
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 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
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 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 Received06/14/2021
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: 07/01/2021 Patient Sequence Number: 1
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