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

Model Number PED-500-20

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

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information that a pipeline failed to open at the distal section.After repeated recycling with marksman, it was found that the tip end of the stent was rough.The device was being used to treat an unruptured saccular aneurysm in the left ophthalmic artery segment.The aneurysm had a max diameter of 16 mm and a neck diameter of 6 mm.The distal landing zone was 4.0 mm and the proximal landing zone was 5.0 mm.Vessel tortuosity was moderate.Access vessel was the femoral artery.  during the deployment process of the 5.0-20 pipeline, after repeated attempts, the tip end was always tapered and could not be fully opened.After repeated recycling with marksman, it was found that the tip end of the stent was rough.It was planned to replace pipeline and relocate the whole system.In order to ensure the successful placement of the new pipeline, replaced with the new catheter.The pipeline was not positioned in a bend.More than 50% of the pipelines had been deployed when it failed to open.The pipeline was resheathed less than or equal to 2 times.The pipeline was resheathed and removed with the microcatheter.No patient symptoms or complications were associated with this event.

Manufacturer Narrative

H3: the pipeline flex embolization device and marksman catheter were returned for analysis.The pipeline flex embolization device was returned outside the marksman catheter.No bends or kinks were found with the pipeline flex pusher.The pusher was found intact.The pipeline flex pusher resheathing pad and ptfe sleeves appear to be in good condition; however, the tip coil was found bent.The pipeline flex braid was returned already detached from the pusher; therefore, the braid ends (proximal, distal) could not be identified.The braid ends were found damaged (frayed).One end was found open; however, one end was not fully open.No damages were found with the marksman catheter hub, body, or distal marker/tip.The marksman catheter was flushed, water exited the distal tip.An in-house 0.026¿ mandrel was inserted through the marksman catheter without issue.Based on the device analysis and reported information, the customer¿s ¿failure/incomplete open distal¿ report could not be confirmed.However, the customer¿s ¿pipeline damaged¿ report was confirmed.It is possible the damage found with the pipeline flex braid or the patient¿s ¿moderate¿ vessel tortuosity contributed to the event.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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12246708
• MDR Text Key: 264118332
• Report Number: 2029214-2021-00950
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536019720
• UDI-Public: 00847536019720
• Combination Product (y/n): N
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2023
• Device Model Number: PED-500-20
• Device Catalogue Number: PED-500-20
• Device Lot Number: B002750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR