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

Model Number PED-475-12

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/20/2019

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 after successful deployment of the pipeline flex, during the retrieval of the delivery wire, while pulling the wire back into the phenom.027 micro catheter, just proximal to the resheathing pad the wire broke.The physician could tell by tactile feedback, immediately pulled the wire and micro catheter into the phenom plus and thankfully the wire that broke off got lodged into the phenom plus and was successfully removed.The devices were prepared and used per the instructions for use (ifu).There was no friction or difficulty.

Manufacturer Narrative

Additional information, device evaluation the pipeline flex embolization device was returned for analysis.No bends or kinks were found with the pusher.The distal hypotube with the ptfe shrink tubing was found intact.The pusher was found detached at the distal hypotube weld (solder joint).The distal segment of the pipeline flex pusher (resheathing pad/marker, braid, ptfe sleeves, distal marker, and tip coil) was found detached.The proximal bumper, re-sheathing pad, re-sheathing marker, distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No damages were found with the tip coil.The pipeline flex braid was not returned.The detached pushwire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pushwire end shows elevated tin (sn), iron (fe), oxygen (o), zinc (zn), and chlorine (cl) peaks were detected on the wire surface.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿pushwire detach at hypotube proximal to the wire weld¿ was confirmed.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.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: 9520219
• MDR Text Key: 198739879
• Report Number: 2029214-2019-01297
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016620
• UDI-Public: 00847536016620
• 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: 03/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2022
• Device Model Number: PED-475-12
• Device Lot Number: A873201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1