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

Model Number	PED-475-10
Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and device evaluation anticipated, but not yet begun.Upon completion of the device evaluation a supplemental report will be filed.Related mdrs for this event: 2029214-2019-00892.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that a pipeline flex device did not open at the distal segment during a procedure.Second pipeline flex device tip broke of the pushwire.The patient underwent embolization treatment for an unruptured saccular aneurysm located in left cavernous segment.Measuring 8mmx5mm, landing zone distal 4.5mm proximal 3.5mm.The vessel was moderately tortuous.It was reported that the guidecatheter was placed through the max sheath and placed into the petrous segment for support.The medtronic microcatheter was placed into the middle cerebral artery (mca) and the first device was advanced through the catheter.The pipeline flex device advanced normally but the device failed to open distally.The device was re-sheathed several times in an effort to get the device to open.After several attempts the device was removed and a new device was inserted.The second pipeline device (same lot number) was advanced through the same catheter to the tip of the catheter.The pipeline device was deployed per ifu and as the device was being dragged back into position, the distal end of the pipeline fell into the aneurysm.The pipeline was constrained to allow the device to be advanced again and resistance was noticed while the pipeline was being re-sheathed.The resistance changed suddenly, and it was noticed that the tip wire was disconnected from the delivery system.The physician removed the delivery system, catheter and guide catheter as a unit and all parts of the system were removed successfully without incident.It should be noted that the pipeline device was found in the guide catheter and the tip wire had to be removed from the femoral sheath with hemostats.The physician then completed the case using a non-medtronic stent and coils.There were not any patient symptoms or complications associated with this event.No patient injury was reported.Patient was treated with stent/coil and was angiographically fine post procedure.
Additional Manufacturer Narrative
The pipeline flex was returned without the catheter.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 appeared to be stretched with the ptfe shrink tubing still intact.The pipeline flex pusher appeared to be separated at the distal hypotube.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.Pusher found kinked near the distal tip coil.In addition, kinks and bends were also found on the pusher in the proximal end.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.No other anomalies were observed.The broken end of the pusher was sent out for sem analysis.Based on the sem and analysis findings, the pipeline flex was confirmed to have resistance during resheathing and pushwire separation.The returned pipeline flex pusher was found to be damaged and separated at the distal hypotube.The fracture surface features of the broken end are consistent with tensile overload.From the damages seen on the pipeline flex pusher (kinking/bending), pipeline flex braid (fraying) and hypotube (stretching and separating); it appears there was high force used.It is likely these damages occurred when attempted to retrieve the pipeline flex pusher through the catheter against resistance.It is likely that the patient tortuous anatomy may have contributed to the resistance during resheathing; causing the pusher to become separated.In this event, the user error may have contributed, as the user continued to pull the pushwire against resistance.Since the catheter was not returned, any contribution of the catheter to the issues could not be determined.Per our instructions for use (ifu): "the system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.Discontinue delivery of the device if high force or excessive friction is encountered.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.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.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
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8955979
• Report Number: 2029214-2019-00893
• Device Sequence Number: 2088463
• Product Code: OUT
• UDI-Device Identifier: 00847536016590
• UDI-Public: 00847536016590
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2022
• Device Model Number: PED-475-10
• Device Lot Number: A817769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR