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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-475-30
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  malfunction  
Manufacturer Narrative
Event reported in lieu of analysis results. Analysis of the pipeline flex embolization device (lot no. B129107) found that the pipeline flex pusher distal hypotube was stretched with the shrink tubing pulled back from the proximal bumper. The proximal bumper and resheathing pad were found in good condition. However, the pusher distal core wire was found broken. The phenom 27 catheter was examined. The phenom 27 catheter hub, catheter body, and distal tip were in good condition. However, the pipeline flex braid could be seen still within the catheter hub. The phenom 27 catheter was dissected (cut), and the pipeline flex braid, ptfe sleeves, and tip coil were removed from within the catheter hub. It was observed that the pipeline flex distal core wire broke at the ptfe sleeves. The ptfe sleeves and tip coil were found damaged. The pipeline flex braid ends were found open but damaged (frayed). The broken core wire was sent out for sem (scanning electron micrographic) analysis. Per the analysis report, the wire failed via torsional overload. Based on the device analysis and reported information, the customer¿s ¿resistance/stuck during delivery¿ report could not be confirmed. Based on the investigation conducted, resistance can occur during the device's tracking, deployment, and re-sheathing in distal and tortuous anatomies. It is possible the damage found with the pipeline flex braid or the patient¿s ¿moderate¿ vessel tortuosity contributed to the event. No damage was found with the returned phenom 27 catheter that would have contributed to the reported resistance issue. In addition, it was reported that a continuous flush was maintained. Therefore, the cause for the resistance could not be determined. Based on the formal investigation, separation can occur due to certain use conditions such as excessive force or patient vessel tortuosity. From the damages seen on the pipeline flex pusher (stretching), it appears excessive force may have been used. It is also likely that the reported resistance contributed to the separation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline which became stuck at the distal end of the phenom catheter. The patient was undergoing a procedure for flow diversion treatment of an unruptured saccular aneurysm of the left ophthalmic artery segment. The aneurysm max diameter was 10. 21mm and the neck diameter was 8. 77mm. Vessel tortuosity was moderate. It was reported that all devices were prepared according to the instructions for use (ifu). The phenom was navigated smoothly and in place in the m2 and the pipeline was delivered smoothly. In the m1 segment, the pipeline distal tip opened well. Pulling back and p ositioning was going well. However, it was found during the delivery that the pipeline could not be pushed out further and the phenom catheter also could not be withdrawn to deploy the pipeline. The physician attempted to release the stack in the system but it did not resolve the resistance. After repeated attempts, there was no change and the pipeline remained stuck in the distal end of the catheter. The phenom catheter and the pipeline were withdrawn together from the patient's body and it was found that the two devices were stuck together and could not be separated. It was noted that the catheter was flushed continuously with heparinized saline during the procedure. Both devices were replaced to complete the procedure. There was no harm or injury to the patient. Post-procedure angiography showed that all blood vessels were normal. There was no thrombotic event. The surgery was very successful with no effect from the event. Additional information received reported that there was no damage observed to that phenom catheter or the pipeline device.
 
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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 Key12454345
MDR Text Key271647991
Report Number2029214-2021-01151
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,Followup
Report Date 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-475-30
Device Catalogue NumberPED-475-30
Device Lot NumberB129107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2020
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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