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

Model Number PED-450-12

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Aneurysm (1708)

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received report that the first pipeline (model: ped-450-14, lot: b082276) was delivered but failed to open at the distal end when more than 50% deployed.The pipeline was resheathed 2 or less times.No other techniques or devices were tried to open the pipeline.The physician attempted to resheath the pipeline to remove but the ptfe sleeve seemed to be stuck on the phenom 27 microcatheter so the microcatheter and pipeline were both removed together and replaced.An attempt was then made to implant a pipeline (model: ped-450-18, lot: b084497).During advancement through the internal carotid artery (ica), the phenom 27 microcatheter jumped back.It was thought this may possibly have been due to lack of sufficient support from the intermediate catheter.The pipeline failed to open when less than 50% was deployed.The pipeline was resheathed 2 or less times. no other techniques or devices were tried to open the pipeline.The pipeline was not positioned in a vessel bend.The pipeline was resheathed and removed.A pipeline (model ped-450-12) was then used and opened successfully but was too short and did not cover the aneurysm neck.A fourth pipeline (model: ped-475-14, lot: b031754) was then tried but would not open distally within the already implanted ped-450-12.The ped-475-14 was less than 50% deployed when the failure to open occurred.The pipeline was resheathed more than 2 times without opening successfully. no other techniques or devices were tried to open the pipeline.It was resheathed and removed with the microcatheter.The patient was undergoing a flow diverter implantation procedure to treat an unruptured saccular aneurysm in theleft internal carotid artery (ica).The aneurysm max diameter was 3mm and the neck diameter was 2mm.Vessel tortuosity was moderate.Post-procedure angiography showed the single pipeline was was deployed.The patient had no related symptoms or complications.

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.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.

Event Description

Additional information was received on (b)(6) 2021.It was reported that the doctor does not recall the tip of the catheter being under stress when the catheter jumped.No additional pipeline or other treatment has been administered to address the incomplete neck coverage, and none is planned at this time.No procedural / post-procedural imaging (ct,angio, etc.) are available.

• 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: 12143650
• MDR Text Key: 261693429
• Report Number: 2029214-2021-00843
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Model Number: PED-450-12
• Device Catalogue Number: PED-450-12
• Device Lot Number: B085470
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR