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

Model Number PED-475-25

Device Problem Activation Failure (3270)

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

Event Date 12/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the pipeline failed to open and the braided tip was entangled.The patient was undergoing surgery for treatment of a saccular, unruptured, left carotid cavernous segment aneurysm with a max diameter of 5.1mm and a 4.97mm neck diameter, and a landing zone of 3.07x4.77mm.It was noted the patient's vessel tortuosity was severe.It was reported that the distal tip of the stent could not be opened after trying many methods.More than 50% was deployed, it was resheathed more than two times, a wire/catheter was used, it was not in a bend, but eventually, the pipeline was resheathed and removed from the patient.Outside of the body, it could be seen that the braided wire at the tip end was entangled, and it could not be opened normally by using a marksman in vitro.A new stent was used and the surgery was completed.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a navien and marksman.

Manufacturer Narrative

A1-a4- patient information - additional information d10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated the pipeline flex braid subassembly was returned for analysis.The pushwire was found to be broken from proximal end and from distal hypotube.The distal hypotube was found to be intact and the ptfe pulled back.The proximal bumper, re-sheathing marker and re-sheathing pad were found to be intact.The dps sleeves were found to be intact.The tip coil was found to be intact and not damaged.Due to the condition in which the braid was returned the distal and proximal ends could not be determined.Both ends of the pipeline flex braid were found fully collapsed and frayed.No other damages or anomalies were found with the device.The broken end of the pushwire was sent out for sem analysis.Per the sem analysis report, the fracture failed at the weld area.The inner wire exhibits dimple features consistent with ductile overload failure.Based on the device analysis and reported information, the report of ¿failure/incomplete open distal¿ was confirmed as both ends of the pipeline flex braid was were found to be collapsed and frayed.The customer reported having re-sheathed the device more than 2 times.The customer also reported the vessel tortuosity was severe.It is likely the failure to open is the result of vessel tortuosity or re-sheathing the device more than the recommended two times.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 EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9484648
• MDR Text Key: 208855369
• Report Number: 2029214-2019-01257
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536016774
• UDI-Public: 00847536016774
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2022
• Device Model Number: PED-475-25
• Device Catalogue Number: PED-475-25
• Device Lot Number: A861764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 53