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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-500-20
Device Problems Activation, Positioning or SeparationProblem (2906); Difficult to Open or Close (2921); Positioning Problem (3009); Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 07/02/2018
Event Type  Injury  
Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it was implanted in the patient; therefore, the event cause could not be determined. For 2nd pipeline, please refer to mdr# 2029214-2018-00681. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the distal segment of the medtronic flow diverter would not open as it was deployed and had to be opened by balloon angioplasty. There was no friction or difficulty delivering this flow diverter to the intended location. The middle segment was positioned on a bend. There was stenosis observed so it was decided to balloon angioplasty the section and deploy the second medtronic flow diverter through this section. Upon deploying the second flow diverter more than 50%, the distal and middle section of the flow diverter would not open and started to flatten out. The flow diverter was resheathed and deployed again two times with the same problem occurring. It was noted that the proximal and distal segment of the flow diverter was positioned on a bend. The second flow diverter was then resheathed and removed from the patient. A third medtronic flow diverter was then deployed without any issues. A carotid stent was also deployed through the stenosis. Post procedural angiography showed a good result with stasis in aneurysm and all stents. The multiple stents were needed due to the stenosis. The patient¿s anatomy was noted to be severely tortuous. No patient injury was reported as a result of the event. The patient was undergoing embolization of an unruptured amorphous aneurysm measuring 8mm x 6mm located in the cavernous segment of the left internal carotid artery (ica). The distal and proximal landing zone was 4. 3mm by 5mm. The patient was administered dual antiplatelet treatment (dapt), but the pru level was not known. A continuous flush was maintained during the procedure. The pushwire of the first medtronic flow diverter will not be returned. The second medtronic flow diverter is in the process of being returned.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
9775 toledo way
irvine CA 92618
Manufacturer Contact
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7733817
MDR Text Key115523420
Report Number2029214-2018-00680
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAS
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 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2020
Device Model NumberPED2-500-20
Device Lot NumberA532521
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 Received08/08/2018
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: 07/30/2018 Patient Sequence Number: 1
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