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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 Activation Failure (3270)
Patient Problems Ischemia (1942); Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109); Loss of Vision (2139); Numbness (2415)
Event Date 05/09/2018
Event Type  Injury  
Manufacturer Narrative

The pipeline devices have not been returned for evaluation; product analysis cannot be performed. The devices have not been returned; the reported events could not be confirmed. The causes of the events could not be conclusively determined from the reported information. Mdrs related to this article: 2029214-2019-01074, 2029214-2019-01076. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Zhang, y. , zhang, y. , guo, f. , liang, f. , yan, p. , liang, s. , & jiang, c. (2018). Treatment of small and tiny aneurysms before and after flow diversion era: a single center experience of 409 aneurysms. World neurosurgery, 116. Doi: 10. 1016/j. Wneu. 2018. 04. 213 medtronic literature review found reports of patient complications after pipeline (ped) placement. The purpose of this article was to evaluate ped as the primary treatment modality for small and tiny aneurysms at anterior circulation. The authors reviewed the results of 55 patients. The article describes the following complications: 4 patients experienced minor ischemic events resulting in transient aphasia, limb numbness, or visual ambiguity. All symptoms resolved within hours. 2 patients experienced major ischemia. One of the two patients experienced visual loss of the left eye; angiographic follow-up indicated occlusion of the ophthalmic artery without compensating blood supply from the branches of the external carotid artery. The other patient experienced intraprocedural incomplete opening of the proximal end of the ped. This patient suffered from ischemia postprocedure, and the ica progressed to occlusion on day 3 postoperation.

 
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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 Key9236189
MDR Text Key177285653
Report Number2029214-2019-01075
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberP100018.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 10/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received09/25/2019
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

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