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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-450-20
Device Problems Break (1069); Unintended Ejection (1234); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
The event was reported in lieu of analysis results. Analysis of the pipeline flex embolization device (lot no. B042477) found no bends or kinks with the pipeline flex pusher. The pipeline flex distal hypotube was found stretched with the ptfe shrink tubing pulled back from the proximal bumper. The pusher proximal bumper was found intact. The pusher resheathing pad was found damaged. The pusher distal core wire was found broken. The phenom 27 catheter was examined. The pipeline flex braid was found within the phenom 27 catheter hub. No damage was found with the phenom 27 catheter hub, catheter body, or distal tip. The phenom 27 catheter body was dissected (cut) and the pipeline flex braid and separated pusher distal segment was removed. The pipeline flex distal core wire was found to have broken proximal to the proximal sleeve restraint. The pusher ptfe sleeves and tip coil were found in good condition. The pipeline flex braid ends were found fully open. The braid proximal end was found damaged (frayed); however, the braid distal end was found in good condition. The broken core wire was sent out for sem (scanning electron micrographic) analysis. Per the analysis report, the distal core wire failed via torsional overload. Based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ was confirmed. Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies. Regarding the customer¿s report of ¿device opens prematurely¿ was confirmed as the braid was found deployed in the phenom 27 catheter hub. Possible causes of failure include resistance during delivery, over-manipulation, pusher was torqued/pulled back during insertion or advancing inside catheter, or user resheaths the device more than two times. Regarding the pusher separation, 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 likely the reported resistance during delivery, torquing of the pusher as evident by the torsional overload failure of the core wire, and the patient¿s ¿moderate¿ vessel tortuosity contributed to the events. No defect was found with the returned phenom 27 catheter that would have contributed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline experienced resistance in the phenom 27 microcatheter and was found to be opened prematurely. The patient was undergoing treatment for an unruptured, amorphous aneurysm located in the ophthalmic artery segment. The max diameter was 4mm, and the neck diameter was 2mm. The patient's vessel tortuosity was moderate. The landing zone was 4mm distal and 4. 46mm proximal. The access vessel was the femoral artery, which was 8mm in diameter. It was reported that when the pipeline was pushed into the phenom 27 it encountered resistance in the distal segment. When the pipeline was withdrawn, the pipeline was unloaded from the push guide wire.  the patient did not experience any injury or complications, and angiographic results post procedure were said to be good. The devices were prepared and flushed according to the instructions for use (ifu).
 
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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 Key12214925
MDR Text Key263431520
Report Number2029214-2021-00908
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 07/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-20
Device Catalogue NumberPED-450-20
Device Lot NumberB042477
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2020
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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