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

Model Number PED-500-16

Device Problem Activation Failure (3270)

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

Event Date 12/10/2019

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 distally.The patient was undergoing surgery for treatment of an amorphous, unruptured, right c2 aneurysm with a max diameter of 11mm, a 5mm neck diameter, a 3.9mm distal landing zone, and 4.2mm central side.It was noted the patient's vessel tortuosity was normal.Post-operative blood stream angiography showed an eclipse sign.It was reported that after disengaging the sleeve at m1, deployment was attempted.However, only the distal tip of the ped opened and the body did not.The pipeline was not used in a tortuous part of the vessel, less than 50% deployed, the device was resheathed 3 or more times, the stent was removed, and no additional actions were taken.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.

Manufacturer Narrative

The device was returned for evaluation and the clinical observation was confirmed.Only pipeline flex braid returned without pipeline flex delivery system.As received, the proximal and distal ends of the pipeline flex braid were found to be collapsed and frayed.Based on the device analysis and reported information, the report of ¿failure/incomplete open distal¿ was confirmed as the proximal and distal ends of the pipeline flex braid was were found to be collapsed.It is likely the failure to open is the result of re-sheathing the device more than the recommended two times.The customer reported the device was re-sheathed 3 or more times.Per our instructions for use (ifu), the user should: ¿begin to deliver the device using a combination of unsheathing the pipeline flex with shield embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex with shield has successfully expanded, deploy the remainder of the device.Carefully inspect the deployed pipeline flex with shield embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked.If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex with shield embolization device.Re-sheathing the pipeline flex with shield embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid." 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: 9475497
• MDR Text Key: 208861052
• Report Number: 2029214-2019-01242
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

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 Model Number: PED-500-16
• Device Catalogue Number: PED2-500-16
• Device Lot Number: A836553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 02/24/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR