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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Thrombosis (2100); Paraplegia (2448)
Event Date 12/27/2019
Event Type  Injury  
Manufacturer Narrative
The pipeline device will not be returned for evaluation as it was implanted in the patient. The device was not returned; the reported event could not be confirmed. The cause of the event could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Starling, r. , abouelleil, m. , miley, j. , & carlson, a. P. (2020). Stent-retriever thrombectomy through an occluded pipeline embolization device. Interdisciplinary neurosurgery, 20, 100659. Doi: 10. 1016/j. Inat. 2019. 100659. Medtronic literature review found a report of in-stent thrombosis after pipeline (ped) implantation. The patient underwent ped implantation in the treatment of a 20-mm broad-necked paraclinoid aneurysm. The patient was placed in dual antiplatelets post-procedurally. Six months post-procedure, the patient's clopidogrel was discontinued by the treating physician. The patient then presented to the emergency department approximately seven hours after onset of dysarthria, left-sided facial droop, and left hemi-plegia. Cta demonstrated internal cerebral artery (ica) occlusion from the cervical bifurcation to just distal to the ped with filling of the middle cerebral artery (mca) from the anterior communicating artery (acom). The patient was started on an eptifibatide drip. An emergent magnetic resonance imaging (mri) with perfusion sequencing was performed, which demonstrated small scattered punctate areas of diffusion restriction. The patient underwent emergency thrombectomy achieving tici 3 revascularization and a small residual non-occlusive thrombus within the ped. Post-procedure day 1, the patient had a persistent minor facial droop but had otherwise made a near complete neurological recovery. Follow up mri demonstrated only tiny scattered infarcts, similar to the pre-procedure study. Post-procedure day 5, diagnostic catheter angiogram was done which demonstrated improvement in the residual thrombus and a small amount of filling of the aneurysm. The patient was discharged on aspirin and clopidogrel with plan for a 6 month follow-up angiogram.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9833141
MDR Text Key189333769
Report Number2029214-2020-00226
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 03/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received02/24/2020
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: 03/14/2020 Patient Sequence Number: 1
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