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

Model Number	PED-400-30
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pipeline flex was returned.The pipeline flex pushwire was returned within a dispenser coil and the braid was returned within a syringe.The device was decontaminated.Both ends of the braid were slightly tapered and frayed.The pusher was found bent at a few locations.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The hypotube appeared to be stretched and the ptfe shrink tubing was found still intact.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The tip coil was found broken and was sent out for sem testing.The testing found dimple features that indicate the wire failed via ductile overload.The pipeline flex device could not be used for in-house resistance testing due to its damaged state and due to the braid already being deployed.No other damages or anomalies were found with the devices.Based on the analysis findings, thereport of ¿resistance/stuck during delivery¿ could not be confirmed.From the damages seen on the pipeline flex braid and pusher and tip coil (break); it appears there was high force used.It is likely these damages occurred when it was attempted to advance the pipeline flex through the catheter against the reported resistance.Possible contributors for resistance are patient vessel tortuosity or lack of continuous flush during delivery.Per our instructions for use (ifu): "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 intralumenal 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.¿ the catheter has an inside diameter of 0.027¿ which is compatible for use with the pipeline flex device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that pipeline flex device encountered resistance within the catheter.Ped-400-30 was reported to have encountered resistance within the proximal section of the catheter.The catheter was flushed per the instructions for use (ifu).It is unknown if the catheter was damaged.The pushwire was not damaged.The devices were prepared and used per the instructions for use (ifu).This event occurred during the treatment of a ruptured, saccular, left vertebral artery aneurysm.The max diameter was 7 mm and the neck was 6 mm.The distal landing zone was 3.9 mm and the proximal was 4.02 mm.The vessel anatomy was moderate in tortuosity.No patient injury occurred.

• 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: 9727299
• Report Number: 2029214-2020-00153
• Device Sequence Number: 2500496
• Product Code: OUT
• UDI-Device Identifier: 00847536015999
• UDI-Public: 00847536015999
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: PED-400-30
• Device Lot Number: A867722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/19/2020
• 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