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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-500-16
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline that failed to open at the distal end. The patient was undergoing a procedure for flow diverter implantation to treat an unruptured saccular ophthalmic artery aneurysm. The aneurysm max diameter was 7mm and the neck diameter was 5mm. Vessel tortuosity was moderate. It was reported that the devices were prepared according to the instructions for use (ifu). The phenom27 microcatheter was in place and the pipeline was delivered. However, the distal tip of the pipeline could not be opened after more than 50% of the pipeline was deployed. The middle section of the pipeline was positioned in a bend. The pipeline was resheathed 2 or less times. The pipeline still could not be opened after repeated pushing, pulling, and swinging. Finally the pipeline was resheathed and removed together with the phenom microcatheter. Burrs were observed on the tip of the pipeline with thrombus adhesion observed. Both devices were replaced and the new pipeline was successfully implanted.   there were no patient symptoms or complications associated with this event. Post-procedure angiography shoed slowed flow to the aneurysm and that the patient blood vessels were normal.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12474530
MDR Text Key271490253
Report Number2029214-2021-01168
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S033
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 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-16
Device Catalogue NumberPED-500-16
Device Lot NumberB161965
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/22/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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