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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-450-35
Device Problem Break (1069)
Patient Problems Death (1802); Intracranial Hemorrhage (1891)
Event Date 09/25/2019
Event Type  Death  
Manufacturer Narrative
This is a report for a similar device that is not marketed in the us. Suspect medical device: similar device brand name: pipeline flex w/shield technology model # ped2-450-35 as the device was received in a condition was contradictory to the complaint description. The pipeline flex with shield device pushwire was found detached at the distal hypotube weld (solder joint). This condition was not reported during the time of the event. As received, the pipeline flex embolization device was returned found stuck at the distal segment of the marksman catheter and it could not be pushed or removed. The pipeline flex pushwire was found bent from the proximal end. For further examination, the catheter was cut to remove the pipeline flex. No damages were found with the hypotube. The pushwire was found detached at the distal hypotube weld (solder joint). The re-sheathing pad, re-sheathing marker and proximal bumper were found dislodged. The distal and proximal dps restraints were found to be intact. The dps sleeves were found intact with no signs of damage. No damages were found with the tip coil. The distal end of the pipeline flex braid was not fully opened due to damaged braid and slightly frayed. The proximal end of the braid was fully opened and moderately frayed. Dried blood was present on the braid. The detached pushwire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis. The elemental analysis of the detached pushwire end showed presence of tin (sn). Based on the analysis findings and reported information, we were unable to determine the cause of "separation". From the damages seen on the catheter body (accordioning), pusher (bending/detach), and pipeline flex braid (fraying); 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. It is likely that the patient tortuous anatomy may have contributed to the resistance during delivery. In addition to excessive force, separation can occur due to inadequate solder/tinning. As the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted. Per our instructions for use (ifu): "discontinue delivery of the device if high force or excessive friction is encountered. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel. Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. ¿ related mdr for this event: 2029214-2019-01043. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that resistance was reported to have occurred during the advancement of the pipeline flex with shield device within the distal section of the marksman catheter. This event occurred during the treatment of a giant, right carotid artery aneurysm, that was fusiform. The max diameter of 20mm and a neck of 10mm. The distal landing zone and the proximal were both 4mm. The vessel tortuosity was severe. The aneurysm was unruptured and was reported to have ruptured during the procedure. The pipeline was reported to have not exited the catheter when the aneurysm ruptured. The patient did experience neurological deterioration and was transferred to the intensive care unit on ventilator support. The patient expired 2 days later. Evaluation of the returned device found that pipeline flex with shield device pushwire was found detached at the distal hypotube weld (solder joint). The re-sheathing pad, re-sheathing marker and proximal bumper were found dislodged.
 
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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 Key9445502
MDR Text Key170088584
Report Number2029214-2019-01213
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 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/03/2021
Device Model NumberPED-450-35
Device Lot NumberA718155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/10/2019 Patient Sequence Number: 1
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