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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 FA-77350-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 04/05/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Itazu, t. , enomoto, y. , yamauchi, k. , egashira, y. , (&) iwama, t. (2020). A case of delayed intraparenchymal hemorrhage due to h yperperfusion after flow diverter treatment.   journal of stroke and cerebrovascular diseases¿: the official journal of national stroke association, 29(8), 104869. Https://doi. Org/10. 1016/j. Jstrokecerebrovasdis. 2020. 104869 medtronic received a literature article pertaining to a case of delayed intraparenchymal hemorrhage caused by hyperperfusion after pipeline treatment of a large internal carotid artery aneurysm. It was reported that, post procedure, the patient's stenosis improved and the circulation time of right hemisphere seemed to be shortened. The patient did not complain any neurological symptoms or headache, and their postoperative condition was good until the postoperative. However, on postoperative day 3, they suddenly presented with disturbance of consciousness and the subsequently performed head ct showed intraparenchymal hemorrhage in the right parietal lobe. Endoscopic hematoma removal was performed on postoperative day 4 and their consciousness disturbance was recovered.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10999678
MDR Text Key221532771
Report Number2029214-2020-01293
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFA-77350-18
Device Catalogue NumberFA-77350-18
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 Received11/14/2020
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

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