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

Model Number PED2-500-20

Device Problems Positioning Failure (1158); Activation Failure (3270)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 # = ped2-500-20 change the model number as needed.The pipeline flex with shield device has not been returned for evaluation; therefore, product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline did not open.It was reported that there was not adequate expansion of the stent, as the distal portion did not open.A new stent was used which worked properly.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 right internal carotid artery.The max diameter of the aneurysm was 12 mm.

Manufacturer Narrative

No damages were found with the marksman hub; however, the pipeline flex pushwire was found extending ~45.7cm from the marksman catheter hub and extending ~1.5cm from distal tip.No bends or kinks were found with the catheter body.No damages were found with the distal tip.An attempt was made to remove the pipeline delivery system from the marksman catheter, however; the delivery system was unable to be removed due to high resistance at the distal section of the catheter body.In order to remove the pipeline flex delivery system from the marksman catheter the marksman catheter was cut, and the delivery system was then able to be removed.No bends or kinks were found with the pipeline flex pushwire.The distal hypotube was found to be intact.The ptfe was found to be pulled back.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.Both ends of the pipeline flex braid were found to be collapsed and frayed.The dps sleeves were found intact and not damaged.The tip coil was found to be intact.The catheter was destroyed during removal of the pipeline delivery system.No device malfunction was reported for the marksman catheter.Based on the device analysis and reported information, the customer¿s report of ¿failure/incomplete open distal¿ was confirmed as both ends of the pipeline flex braid were found to be collapsed.It is likely failure to open is the result of vessel tortuosity or re-sheathing the device more than the recommended two times.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9997492
• MDR Text Key: 189186242
• Report Number: 2029214-2020-00398
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2021
• Device Model Number: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: A732874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1