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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-300-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Apheresis (1719); Infarction, Cerebral (1771); Paresis (1998)
Event Date 04/16/2018
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received information through clinical study that post procedure patient experience right hemiparesis and aphasia has been assessed by site to have causal relationship to study procedure. The event was resolved on the same day. Additional information updated the event to a stroke. The patient underwent embolization treatment for a flow diversion of saccular left anterior cerebral artery bifurcation branch, measuring 13mmx9mmx13mm, neck 5mm, parent artery diameter distal 1. 8mm, proximal 2. 3mm. Post procedure complete stasis and class 2 occlusion. Next day of the procedure patient discharge home with self care. At six month follow up patient had class 1 aneurysm occlusion and 0-25% parent artery stenosis. Mrs score 0. No new events identified. History: occlusion of the left anterior choroidal artery due to the misplacement of a coil loop, the coil is not related to the target aneurysm. Severity moderate and the ae treated with a percutaneous intervention and concomitant or additional medication given. Per the information provided in the casebook, the subject had previous rupture on (b)(6) 2017. The date of past procedures and past treatment information is not collected in the study.

 
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Brand NamePIPELINE FLEX
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
7635263305
MDR Report Key8843518
MDR Text Key152710422
Report Number2029214-2019-00796
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberP100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/15/2018
Device MODEL NumberPED-300-16
Device Catalogue NumberPED-300-16
Device LOT NumberA058829
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2019
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: 07/30/2019 Patient Sequence Number: 1
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