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

Model Number PED-475-16

Device Problem Activation Failure (3270)

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

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that 2 pipeline flex device failed to open.The left ica was tortuous leading up to the aneurysm- the aneurysm being located just distal to the anterior genu and the origin of the ophthalmic artery.There was difficulty getting any wire to pass the pcom branch to get to the mca to allow the phenom 27 to track.After successfully getting the wire (transcend) to the m1, the case proceeded.A total of 3 pipeline devices were used- only the final device was deployed.The first device opened was a 4.75x16 consigned product lot a835655, which did not open when placed in the m1.Only very distal opening was observed, and the device was pulled back to a larger diameter vessel and more of the device released to see if it would open.The ptfe sleeves were "bumped" back without successful device opening.More support was garnered from the navien and phenom- loading the entire system without successful opening of the device.This device was then removed and a 4.75x14 (trunk stock) device was opened lot a873205.This device behaved in a similar fashion- with a ribbon shaped appearance angiographically.After much manipulation of the device it became clear that it would not "flower" distally, middle or proximally.This device was removed (noted to be frayed on the most distal aspect).A third device, 4.75x16 (trunk stock) device was opened lot a906734 and went through the same steps as the first two devices.This device was observed to open as intended and was successfully placed in the ica across the neck of the aneurysm.The pipeline flex and any accessory devices were prepared as indicated in the instructions for use (ifu).The pipeline devices were placed in a bend in the anatomy.The bend was in the middle.More than 50% of the device was deployed when it failed to open.More than 50% of the device was deployed when it failed to open.The device was resheathed 2 times.No additional steps were made to open the device.The aneurysm was in the left ica paraophthalmic.The aneurysm was unruptured.The max diameter was 9.5mm and the neck was 10mm.The distal landing zone was 3.8mm and the proximal was 4.8mm.The vessel anatomy was severe in tortuosity.

Manufacturer Narrative

The pipeline flex braids (a835655 and a873205) were returned within a syringe barrel.The pipeline flex braids were returned without their pushwire.The reason for the pushwires not returning was not provided.The pipeline flex braids were decontaminated.As the pipeline flex braids were returned detached from the pushwires, the distal and proximal ends of the braid were unable to be identified.The pipeline flex braid ends were found damaged (frayed); however, both ends of the braids were found open.No other anomalies were observed.Based on the device analysis and reported information, the report of ¿failure/incomplete open¿ could not be confirmed.In this event, use context likely contributed to the event as the braids were reported to be deployed in vessel bend.In addition, as the patient vessel tortuosity was ¿severe¿ it is likely that the braids were overstretched during delivery which may have contributed to ¿failure/incomplete open¿ issue.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: 9511150
• MDR Text Key: 209012143
• Report Number: 2029214-2019-01287
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016682
• UDI-Public: 00847536016682
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2022
• Device Model Number: PED-475-16
• Device Lot Number: A835655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR