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

Model Number PED-500-18

Device Problems Detachment of Device or Device Component (2907); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

The device involved in the event has not been returned as the pipeline was implanted in the patient; therefore the event cause could not be determined.Correspondence has been sent out for return of the pushwire and additional information.Once the device has been received and investigation completed.A supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the medtronic flow diverter could not be fully opened in the middle segment to oppose the vessel walls.The delivery pushwire was also reported to be broken.Prior to the reported event, the physician was struggling to get the middle of the medtronic flow diverter to fully open and attempted to push the medtronic guide catheter over the delivery wire which was believed to have broken the delivery wire at the proximal marker because it was not fully open at that location.The physician commented that they did not realize the flow diverter was fully deployed so they wagged the device and the guide catheter advanced over the delivery wire which may have broken the wire.Post procedural angiography showed the middle portion of the medtronic flow diverter was only 20% open.The distal part of the flow diverter¿s delivery wire separated at the proximal marker band.The middle segment of the flow diverter was then ballooned to approximately 40%.The pushwire delivery system that was separated was in the m3 artery.There was good enough flow through the pipeline and to all the distal arteries.The patient was undergoing embolization treatment of a unruptured amorphous aneurysm measuring 5mm x 3mm located in the ophthalmic segment of the left internal carotid artery (ica).The distal and proximal landing zone was 4mm x 4.90mm.The patient¿s vasculature was moderate in tortuosity.

• Brand Name: PIPELINE FLEX
• 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: 9621795
• MDR Text Key: 186733464
• Report Number: 2029214-2020-00066
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2022
• Device Model Number: PED-500-18
• Device Lot Number: A895296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• Date Device Manufactured: 09/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 55 YR