MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL 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 Key: 9445502
• MDR Text Key: 170088584
• Report Number: 2029214-2019-01213
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• 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 Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/03/2021
• Device Model Number: PED-450-35
• Device Lot Number: A718155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• 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