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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-425-25
Device Problem Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2019
Event Type  malfunction  
Manufacturer Narrative
As received the device for investigation, the pipeline flex pushwire was found separated proximal to the dps sleeves.This condition of the device was not reported initially.It was found the pipeline flex embolization device was returned within the marksman catheter.The pipeline flex pushwire was found protruding from within the marksman hub.The pipeline flex delivery system could not be pushed forward or pulled back from within the marksman as it appears to be locked up within the distal segment of the marksman.For further examination, the marksman catheter was dissected at several locations; however, only the distal end of the pipeline flex delivery system was able to be uncovered.The uncovered section of distal hypotube was found stretched with the ptfe shrink tubing still intact.However, the pipeline flex pushwire was found separated proximal to the dps sleeves.The pipeline flex braid was not returned and the dps sleeves with tip coil were found separated and not returned.The pipeline flex pushwire was sent out for scanning electron microscope (sem) failure analysis.Based on the device analysis, reported information and sem report, ¿the pushwire failed via torsional overload.¿ it is likely the pipeline flex pushwire separated as the user continued to retrieve the device against resistance.Related mdr for this event: 2029214-2019-00277.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that after the marksman microcatheter was in place, the pipeline flex was delivered, the large resistance occurred, the stent cannot be pushed out of the microcatheter.The patient underwent embolization treatment for a small unruptured saccular left internal carotid artery aneurysm, measuring 8mmx5mm, landing zone distal 3.95mm, proximal 4.20mm.There were not any patient symptoms or complications associated with this event.No patient injury was reported.Evaluation of the returned device found that the pipeline flex pushwire was found separated proximal to the dps sleeves.
 
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Brand Name
PIPELINE FLEX
Type of Device
INTRACRANIAL 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 Key8749508
MDR Text Key149680141
Report Number2029214-2019-00653
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/16/2021
Device Model NumberPED-425-25
Device Lot NumberA725107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/26/2019
Initial Date FDA Received07/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age60 YR
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