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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problems Positioning Failure (1158); Activation Failure (3270)
Patient Problems Stroke/CVA (1770); Embolism (1829); Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982); Loss of Vision (2139); Shaking/Tremors (2515)
Event Date 04/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Fei liang, yupeng zhang, feng guo, yuxiang zhang, peng yan, shikai liang, yuhua jiang, peng jiang, chuhan jiang. (2018). Pipeline em bolization device for posterior circulation aneurysms: single-center experiences with comparison with anterior circulation aneurysms, 112. Doi: 10. 1016/j. Wneu. 2018. 01. 129. Medtronic literature review found a report of patient complications after pipeline implantation. The purpose of the article was to evaluate the performance of the pipeline embolization device (ped) for posterior circulation aneurysms. The authors retrospectively reviewed the results of 35 patients with 38 posterior circulation aneurysms who underwent treatment with the ped and compared them to 163 anterior circulation aneurysms. The article describes the following posterior circulation aneurysm events: - out of the 37 procedures, 2 procedures encountered insufficient opening of the ped. It was stated that 2 malappositions occurred when the stenosis of the parent artery restricted the opening of the proximal part of the ped. These 2 cases ended up with parent artery occlusion. 1 of the patients with bilateral dissecting aneurysms experienced postprocedural subarachnoid hemorrhage. It was decided to operate these aneurysms in 2 sessions and to deploy the ped in the dominant va (right) first. Subarachnoid hemorrhage was confirmed 1 day postprocedure by computed tomography scan with hyperdensity evident in the left sylvian fissure and ambient cistern. Clopidogrel was discontinued for 1 month until the left v4 segment aneurysm was treated. Because of the restriction by the stenosis of the parent artery, the ped was not fully opened even after angioplasty. Dsa follow-up after 7 months showed occlusion of the va, and the left posterior inferior cerebellar artery (pica) was patent with retrograde filling from the right side. Near occlusion of the parent artery occurred in the other case because the portion of the ped proximal to the stenosis did not fully expand. - 2 patients had minor ischemic stroke after the procedure. One of the patients harbored a vbj aneurysm; the patient presented transient blindness of the right eye, but the symptoms resolved 1 day later. The other patient with subacute cerebellar infarction and ataxia on admission experienced slight directional tremor postoperation. During the procedure, the pica was covered by the ped; however, the symptom of the patient completely relieved 2 days later. The article describes the following anterior circulation aneurysm events: - 3 patients experienced subarachnoid hemorrhage post preocedure. - 19 patients experienced minor ischemic stroke post procedure. - 6 patients experienced major ischemic stroke post procedure. - 1 patient experienced a delayed complication of intraparenchymal hemorrhage. - 3 patients experienced a delayed complication of parent artery occlusion.
 
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Brand NamePIPELINE 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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9168050
MDR Text Key166669433
Report Number2029214-2019-01000
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
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 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberNOT-REP
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 Received09/19/2019
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: 10/08/2019 Patient Sequence Number: 1
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