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

Model Number PED2-400-18

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

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information regarding a pipeline that had issues with the proximal end during deployment.The patient was undergoing a procedure for flow diversion treatment of an unruptured aneurysm of the right internal carotid artery (ica).Vessel tortuosity was minimal.It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu).After depl oyment, the physician pushed the microcatheter through the pipeline in order to retrieve the delivery system as per the ifu.During this maneuver, the proximal end of the pipeline was pushed into itself.After removing the herniated part within the microcatheter, the proximal end of the pipeline stent was not opened properly and also appeared twisted.Troubleshooting attempts were made to try to open proximal end and resolve the twist using a solitaire x but it was not successful.By trying to re-enter the stent, the same issue occurred and the proximal end of the pipeline herniated into itself.Another attempt was made with a preset 3mm without success.Finally an attempt was made with a solitaire ab (sab) and the physician ultimately detached the sab in order to keep the proximal end of the pipeline open as much as possible with full wall apposition achieved.It was noted that the pipeline was not positioned in a vessel bend.More than 50% of the pipeline had been deployed when the failure to open occurred.The pipeline was resheathed less than or equal to 2 times.  no patient symptoms were reported.

Manufacturer Narrative

G4: pma # p100018.S026 was omitted from previous report in error.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: 11783459
• MDR Text Key: 249266093
• Report Number: 2029214-2021-00546
• Device Sequence Number: 1
• Product Code: OUT
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: PED2-400-18
• Device Catalogue Number: PED2-400-18
• Device Lot Number: A974576
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR