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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number UNKNOWN
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2019
Event Type  malfunction  
Manufacturer Narrative
As the device was received, found that pipeline flex pushwire was found separated proximal to the dps sleeves. This device issue did not reported during the time of the event. This device received as an extra device. Unknown pipeline flex embolization device was returned medtronic catheter. The pipeline flex delivery system was returned outside the catheter. No bends or kinks were found with the pipeline flex pushwire. The pipeline flex distal hypotube was found stretched. The ptfe shrink tubing was intact but pulled back from the proximal bumper. The proximal bumper, re-sheathing pad and re-sheathing marker were found intact. The pipeline flex pushwire was found separated proximal to the dps sleeves. The pipeline flex dps sleeves with tip coil were not returned. The pipeline flex braid was found within the catheter hub. The catheter body was cut proximal to the catheter kinking. A mandrel was inserted into the catheter and the pipeline flex braid was pushed out from within the catheter hub. The pipeline flex braid ends were found fully opened and in good condition. The pipeline flex dps sleeves with tip coil were not found with the catheter. No other anomalies were observed. The pipeline flex pushwire will be sent out for sem failure analysis. Per the sem report, most of the fracture surface was smeared and corroded. Small areas exhibited dimple features consistent with a torsional overload failure. The customer did not reported this event. Without any detail of the event, we were unable to determined the cause of the event. Pushwire break/separation can be caused by patient vessel tortuosity, resistance of delivery wire during delivery/retrieval, over-manipulation, or user resheaths more than 2 times. From the damages seen with the pipeline flex pushwire, it appears there was high force used. It is likely these damages occurred when the attempted to advance the pipeline flex through the catheter against resistance. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received extra device for analysis. Evaluation of the extra returned device found that pipeline flex pushwire was found separated proximal to the dps sleeves.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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 Key9720537
MDR Text Key196774922
Report Number2029214-2020-00151
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 02/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberNOT REPORTED
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2020
Was Device Evaluated by Manufacturer? Yes
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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