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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-400-16
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 04/17/2020
Event Type  malfunction  
Manufacturer Narrative
As the device was received in a condition was contradictory to the complaint description. The pipeline flex device pushwire tip found broken. This condition was not reported at time of the event. As received, the pipeline flex embolization device was returned within its introducer sheath. No damages were found with the introducer sheath. The pipeline flex embolization device appears to be in good condition within the introducer sheath. The introducer sheath was inserted into an in-house rotating hemostatic valve (rhv) and the rhv was tightened around the introducer sheath. The device was backflushed with water without issue. For further examination, the pipeline flex was pushed out from the introducer sheath without issue, deploying the braid. The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation. The proximal bumper, resheathing pad, and resheathing marker were found intact and in good condition. The distal, middle and proximal segment of the pipeline flex braid were fully open and in good condition. The ptfe sleeves, distal marker, and tip coil were found dislodged from the distal pushwire. The tip coil ball weld was found missing. No breaks or separations were found with the distal pushwire. No other anomalies were observed. Based on the returned device analysis and reported information, we were unable to determined the cause of the event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that resistance was observed in the pipeline preoperatively inside sheath. It was reported that it was not possible to purge the device with solution prior to the procedure. Resistance was observed in the device when done manually. The patient did not experience any injury or complications. The devices were prepared according to the instructions for use (ifu). The patient was undergoing treatment for an unruptured, saccular aneurysm located in the posterior communicating artery. The max diameter was 6 mm, and the neck diameter was 4 mm. The landing zone was 4 mm distal and 4 mm proximal. Vessel tortuosity was normal. Dual antiplatelet treatment was administered using clopidroge 600 mg, asa 300 mg. The angiographic results post procedure were normal. Evaluation of the returned device found that the tip coil ball weld was found missing from the delivery system. During the analysis, the ptfe sleeves, distal marker, and tip coil were found dislodged from the distal pushwire.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10226402
MDR Text Key197607708
Report Number2029214-2020-00649
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCO
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 07/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/15/2020
Device Model NumberPED-400-16
Device Lot NumberA557606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2017
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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