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

Model Number	PED-500-10
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that one pipeline did not achieve full wall apposition initially, and the second pipeline failed to open distally.A third pipeline was used to fully open the first pipeline.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right internal carotid artery with a max diameter of 5mm and a 5mm neck diameter.It was noted the patient's vessel tortuosity was severe.It was reported that the pipeline (pli-20) was implanted but was not fully apposed to the distal portion of the landing zone.A second pipeline (pli-10) was used in an attempt to open the first pipeline, but this second pipeline would not fully open in the distal segment.The pipeline was removed without incident and another pipeline was used in its place.It was noted the middle section of the pipeline was positioned in a bend, more than 50% was deployed, and resheathing was done more than twice.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.Post-procedure angiographic results showed good results and the device was open.Ancillary devices include a 6fr neuron max, phenom plus, phenom 27, tracesses.014.

• 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: 10532397
• Report Number: 2029214-2020-00925
• Device Sequence Number: 11568713
• Product Code: OUT
• UDI-Device Identifier: 00847536016866
• UDI-Public: 00847536016866
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/14/2020

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: 11/09/2020
• Device Model Number: PED-500-10
• Device Catalogue Number: PED-500-10
• Device Lot Number: A554500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1