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

Model Number PED-425-18

Device Problems Break (1069); Retraction Problem (1536)

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

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

The device involved in the event has been received; however, the investigation has not been completed.Once the device has been evaluated and the investigation has been completed, a supplemental report will be submitted with the results of the investigation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the pushwire of the medtronic flow diverter fractured into to pieces.Prior to the event, the medtronic flow diverter was implanted without any issues.Then the microcatheter was pushed up to retrieve the delivery wire, but the wire would could not be retrieved back into the microcatheter.This is when the reported event occurred.The broken wire was inside the microcatheter; therefore, it was safely removed from the patient.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of an unruptured saccular aneurysm measuring 10mm x 6mm located in the internal carotid artery.The distal and proximal landing zone was 4mm x 4.6mm.The patient¿s vasculature was severe in tortuosity.

Manufacturer Narrative

D10.Device available, return date - additional information.G4.Date manufacturer received - additional information.G7.Type of report - additional information.H2.Follow-up type - additional information.H3.Device evaluation, device returned - additional information.H6.Evaluation codes - additional information, device evaluation.H10.Additional manufacturer narrative - additional information, device evaluation.The pipeline flex pushwire was returned.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pipeline flex pusher found to be separated at the distal hypotube.The outer jacket on the distal hypotube appeared to be pulled back at ~12.0cm from the broken end.Bends observed on the pushwire at 35.5cm to 57.5cm from the proximal end.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.Based on the analysis findings, the pipeline flex was confirmed to have pushwire separation.The returned pipeline flex pusher was found to be separated at the distal hypotube.The dimple features on the surface of the broken end indicate a twist/shear overload failure.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.

• 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: 9107624
• MDR Text Key: 180602487
• Report Number: 2029214-2019-00948
• 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: 11/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2022
• Device Model Number: PED-425-18
• Device Lot Number: A863676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR