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

Model Number PED2-500-14

Device Problems Material Deformation (2976); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the pipeline failed to open proximally.The patient was undergoing treatment for a ruptured, amorphous aneurysm located in the ica.The patient's vessel tortuosity was severe.The landing zone was 3.23mm distal and 4.25mm proximal. dual antiplatelet treatment was not administered.It was reported that distal and mid section of the pipeline opened normally.The proximal and middle sections of the pipeline had been placed in a bend.More than 50% of the device had been deployed when it failed to open.The pipeline had been resheathed more than 2 times.The physician snared the unopened device, and it was removed. angiographic results post procedure were said to be good. the patient did not experience any injury or complications.It was noted that the devices were not prepared according to the instructions for use (ifu); the pipeline was flushed manually/aggressively on the back table.Ancillary devices include an infinity sheath, phenom plus guide catheter, and phenom 27 microcatheter.

Event Description

Additional information was received and it was reported that there were two instances of this occurring with the healthcare provider (hcp) for the same patient in the exact same location of the ica.Coming around the second bend it looked clear for the final deployment where the device typically pops open.Both times it remained lazy.One was retrieved will be returned.The other was able to eventually open.The doctor implanted a total of 3 device but attempted 4.1 was snared out and the other was eventually opened and implanted.The one that was snared out was lazy on the proximal end and did not open at all.We have a video of the device being pulled out and if slowed down it looks potentially twisted but cannot confirm.Hcp did not give an indication that it was twisted but my experience tells me that might be the case.Upon further discussion with the physician, one pipeline was snared out and we have.One was implanted and left in.However, a device was also not implanted because it was damaged by their team during the flushing of the device.This unit was discarded and not implanted or saved.Patient as successfully treated with three devices total.All three that were implanted were fully opposed to the vessel wall and the physician was happy.Came to the final understanding that their was most likely something specific to the landing zone that impacted the ability for the stents to fully open.Since this case, hcp has continued to use shield successfully with 4 additional patients and remains confident using this device.

Manufacturer Narrative

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: 12108608
• MDR Text Key: 259683880
• Report Number: 2029214-2021-00808
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284695
• UDI-Public: 00763000284695
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: PED2-500-14
• Device Catalogue Number: PED2-500-14
• Device Lot Number: B180094
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1