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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-500-20
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that there was a kink in the pipeline causing an inability to open about 2-3mm proximal to the distal end. As a result the physician resheathed the device and deployed the device two times but the issue recurred. The system was then replaced and the procedure completed successfully. The patient was undergoing treatment of an unruptured, amorphous right cavernous ica aneurysm with a max diameter of 30mm and a neck diameter of 7mm. It was noted that the patient's vessel tortuosity was severe. There were no additional steps to attempt to open the pipeline.
 
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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 Key10968825
MDR Text Key220247762
Report Number2029214-2020-01247
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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 02/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-20
Device Catalogue NumberPED-500-20
Device Lot NumberA764356
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2021
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

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