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

Model Number PED2-500-20

Device Problems Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.The device involved in this event is not approved in the us; the device's brand name and model number are provided below.This report is being filed against a similar device, which is provided in section.Brand name: pipeline flex with shield technology model number: (b)(4).Mdrs related to this event: 2029214-2019-00476 2029214-2019-00477.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of pipeline flex with shield failure to open during a procedure.The patient was undergoing treatment of an unruptured, amorphous aneurysm with a max diameter of 7.63mm and a neck diameter of 5.63mm.It was noted that the vessel tortuosity was normal.The devices were prepared as indicated per the ifu.It was reported that during a procedure, while in the m1 segment trying to perform a "drop and drag" method, the pipeline device got stuck within distal end of the microcatheter and failed to open during deployment, causing the whole system to slip back due to the force.As a result of the issue the pipeline was removed with the microcatheter.The procedure was completed using a new device.Post procedure angiographic results were satisfactory.

Manufacturer Narrative

The pipeline flex with shield was returned within the catheter.For further examination, the pipeline flex with shield was pushed out from the catheter lumen with no issues.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The outer diameter (o.D) of the re-sheathing pad was measured within specifications.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal ends of the pipeline flex with shield braid were fully opened and moderately frayed.No bends found on the pusher.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip, marker band and body were examined; and no damages were found.No flash or voids molded were observed in the hub.The catheter was flushed with water and found to be patent.The catheter was then tested by running an in-house mandrel through catheter hub, lumen and tip.The mandrel was able to pass through the hub, lumen and tip with no issues.Based on the analysis findings, the pipeline flex with shield and catheter were not confirmed.The event cause could not be determined as the returned pipeline flex with shield was able to push out from the catheter lumen with no issues.No damages found with the returned pipeline flex pusher and catheter.The pipeline flex with shield braid appeared to be fully opened and moderately frayed at both ends.The damage on the ends of the braid is likely the results of re-sheathing the device more than the recommended two times.Per our instructions for use (ifu): the user should "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Re-sheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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 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: 8629818
• MDR Text Key: 145765229
• Report Number: 2029214-2019-00476
• 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: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: PED2-500-20
• Device Lot Number: A702683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 65