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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Visual Impairment (2138); Brain Injury (2219); No Code Available (3191)
Event Date 02/20/2018
Event Type  Injury  
Manufacturer Narrative
The reported adverse event of ocular motility disorder and mass effect was reported to have occurred approximately two years post uneventful pipeline embolization procedure. The patient's mrs post procedure was 0. The patient's 1 month, 6 month, and 1 year follow up did not show any changes. At the two year follow-up, the mrs changed from 0 to 1 and the adverse events were reported. It was also noted that the adverse events were not related to the device and not related to the procedure. Correspondence has been sent out for more information regarding the event. Once received, a supplemental will be submitted. Reference mdr# 2029214-2018-00688. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the patient developed ocular motility disorder approximately two years post procedure involving two flow diverters. The patient underwent uneventful flow diverter embolization treatment for an unruptured saccular aneurysm measuring 25mm with neck width of 13. 5mm located in the paraclinoid segment of the left internal carotid artery (ica) approximately two years ago. There was not device malfunction and the flow diverters were implanted successfully in the intended location. The mrs was 0 post procedure. During follow up 7 days post procedure, the mrs was still 0 and there were no adverse events reported. The patient continued with 1 month, 6 month, and 1-year follow-up yielding the same results as the 7 day follow up. No adverse events. During the 2-year follow up, the patient¿s mrs had changed from 0 to 1 and there was some mass effect. The patient had developed an adverse event of ocular motility disorder and the occurrence was unknown. The adverse event was not labeled as device related or procedure related.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7737197
MDR Text Key115647435
Report Number2029214-2018-00689
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.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 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-500-18
Device Lot NumberA067099
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 Received08/08/2018
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: 07/31/2018 Patient Sequence Number: 1
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