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

Model Number	PED-475-35
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis as it was discarded at the site.Possible contributing factors of "failure/incomplete to open at middle section" include damage to the pipeline braid, patient tortuous anatomy and deployment of the device on a bend.It is not recommended to initiate deployment of the device on a bend.All products are 100% inspected for damage and irregularities during manufacture.Per our instructions for use (ifu): "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 has successfully expanded, deploy the remainder of the device.Carefully inspect the deployed pipeline flex 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 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.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".If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that 2 pipeline flow divertors failed to expand in the middle segment.This event was reported have occurred during the treatment of internal carotid artery, unruptured aneurysm.The anatomy was reported to have been severe in vessel tortuosity.The middle segment of the device was placed on a bend.Both devices were deployed more than 50% when it failed to open.The devices were re-sheathed more than 2 times.No additional steps were made to open the devices and each one was removed with the catheter.A new device was successfully used to treat the patient.No patient injury reported.The devices were prepared and used as indicated in the instructions for use (ifu).

• 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: 8696472
• Report Number: 2029214-2019-00551
• Device Sequence Number: 2246966
• Product Code: OUT
• UDI-Device Identifier: 00836462015906
• UDI-Public: 00836462015906
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 06/13/2019

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 Model Number: PED-475-35
• Device Lot Number: A759403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR