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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-325-16
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/18/2016
Event Type  Injury  
Manufacturer Narrative
The pipeline flex has not been returned for evaluation; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. There was very limited information provided in maude database and also there was not any contact information available for this event; therefore, unable to obtain the additional information. Upon receipt of the device and/or additional information a supplemental report will be filed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
This event is captured from mw5061960 (maude). Medtronic receive information through regulatory body that pipeline flex device pushwire separation during the procedure. It was reported that the physician inserted a pipeline flow diverter. Placement of the device was satisfactory, however, the delivery wire fractured and could not be retrieved. There was unintended separation of the delivery wire device, resulting in a small wire remnant, which was left behind in the brain circulation, and secured with additional neuroform stenting, telescoping through the pipeline. The proximal end of the delivery wire was "trapped" between the stent and the vessel wall so that it could not migrate or cause a blood flow problem.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key10074946
MDR Text Key195543379
Report Number2029214-2020-00469
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,user f
Reporter Occupation
Type of Report Initial
Report Date 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-325-16
Device Lot NumberUNKNOWN
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 Received05/08/2020
Was Device Evaluated by Manufacturer? No
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: 05/20/2020 Patient Sequence Number: 1
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