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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 PED-350-16
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/23/2019
Event Type  malfunction  
Manufacturer Narrative
As the device was received in a condition was contradictory to the complaint description. Returned device found that the pipeline flex pushwire was found broken. Also the catheter body it was found under the vis what appeared to be a wire protruding from the catheter body. This condition was not reported during time of the event. As received, the pipeline flex embolization device and marksman catheter were returned for analysis. The distal hypotube was found to be stretched and ptfe shrink tubing was found to be pulled back ~0. 9mm with no signs of elongation. The proximal bumper and re-sheathing marker were found to be intact. The re-sheathing pad appeared to be good condition. The tip coil, braid and distal dps restraints were found to be missing. The pushwire was found broken. The marksman catheter body was found to be kinked at ~25. 2cm and ~11. 9cm from distal tip. No damages were found with the distal tip. The pipeline flex braid appeared to be stuck inside the marksman catheter hub. The braid was then able to be removed from the hub of the marksman catheter. Upon further analysis of the catheter body it was found under the vis what appeared to be a wire protruding from the catheter body where resistance was felt. The marksman catheter was then cut at the section of resistance and the missing distal segment (tip coil and distal dps restraints) was then removed. The proximal and distal ends of the pipeline flex braid were found fully open. The proximal end of the pipeline flex braid was found to be damaged. The tip coil core wire was found to be broken. The dps sleeves were found to be intact. The ends of the broken pushwire were sent out for sem (scanning electron micrographic) analysis. Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and t ortuous anatomies. However, the cause for the resistance could not be determined. Based on the investigation conducted, use condition such as excessive force and patient vessel tortuosity can contribute to the event. Separation can occur if excessive force is used exceeding the tensile strength of the material. Two samples of the broken ends of the core wire were sent out for sem (scanning electron micrographic) analysis. Per the sem analysis report for sample 1, the wire exhibits features indicative of tool cutting/snipping. Per the sem analysis report for sample 2, the fracture surfaces exhibit dimple features consistent with torsional overload failure mechanism. However, no definitive conclusions can be provided. From the damages seen on the pipeline delivery system tip coil (stuck within catheter body and broken) and pusher (broken); it appears there was high force used. It is likely these damages occurred when the customer attempted to advance the pipeline flex through the marksman catheter against resistance. However, the cause of the event could not be determined. Related mdrs for this event: 2029214-2019-01246. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that resistance was experienced when the pipeline flex was advanced with the marksman catheter lumen. A new stent and catheter were used to treat the patient. This event occurred during the treatment of a saccular, left middle cerebral artery aneurysm. The anatomy was minimal in tortuosity. Evaluation of the returned device found that the pipeline flex pushwire was found broken. Also the catheter body it was found under the vis what appeared to be a wire protruding from the catheter body.
 
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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 Key9476937
MDR Text Key209004121
Report Number2029214-2019-01245
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
Type of Report Initial
Report Date 12/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/26/2022
Device Model NumberPED-350-16
Device Lot NumberA805487
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2019
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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