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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-400-20
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2019
Event Type  malfunction  
Manufacturer Narrative
This is a report for a similar device that is not marketed in the us. Suspect medical device - similar device brand name
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pipeline flex w/shield technology model #
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ped2-400-20 as the device was received, pipeline flex with shield device was partially within an introducer sheath with the braid and distal sub -assemblies found stuck within the hub of the medtronic catheter. Strong resistance was felt when removing the pipeline flex with shield device form the medtronic catheter. The dps wing, and tip coil outer coil broke and became stuck within the proximal end of the catheter along with the braid subassembly. Distal inner wire that is normally under the tip coil outer coil was found intact. No damages or irregularities were found with the pushwire. The distal and proximal dps restraints were found to be intact. The hypotube appeared to be intact and with no stretching and the ptfe shrink tubing was found still intact. No damages were found with the distal marker, re-sheathing marker or with the proximal bumper. A tweezer was used to pull out the braid from the catheter hub. The proximal end of the braid fully opened with fraying observed. The distal end of the braid did not fully open (hourglass) with fraying observed. The dps wing was found entangled with the braid fiber. The braid subassembly was placed within an ultrasonic cleaner and the braid fully opened once the coagulated blood was dissolved. The catheter was cut, and a mandrel was used at the proximal section. Dried blood and the tip coil outer coil were pushed out. Both solder ends of outer coil was broken however the coil itself appears undamaged. Based on the returned device analysis, these damages occurred when the customer attempted to retract the pipeline flex with shield device through the catheter and into the sheath against resistance. From the damages seen on pipeline flex with shield braid (frayed ends), tip coil outer coil (break) and dps wings (break); it appears there was high force used. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the pipeline encountered difficulties when it was used with the marksman catheter. The pipeline was able to exit the catheter tip and encounter resistance when attempted to be resheathed. The resistance was in the middle distal section. The pipeline was not implanted and was removed with the catheter. The devices were prepared and used per the instructions for use. The catheter was flushed as per the ifu. This event occurred during treatment of an unruptured, cavernous aneurysm, that was fusiform. The anatomy was moderate in tortuosity. Evaluation of the returned device found that the dps wing, and tip coil outer coil broke from the 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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9813960
MDR Text Key207393251
Report Number2029214-2020-00211
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
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 03/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/09/2020
Device Model NumberPED-400-20
Device Lot NumberA457749
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2017
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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