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

Model Number	PED-450-35
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
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 the proximal section of the pipeline failed to open.The patient was undergoing surgery for treatment of a fusiform, unruptured, left aneurysm with a max diameter of 7mm and a 20mm neck diameter, and a landing zone of 3.75x3.5mm.It was noted the patient's vessel tortuosity was severe.It was reported that the first two of three pipelines were well expanded when releasing the stent, but the last pipeline was kinked and the proximal section could not open.The pipeline was not positioned in a bend, more than 50% was deployed when it failed to open, it was re-sheathed more than two times, and no additional steps or other devices were used to try and open the pipeline.After several attempts to drag it, the stent was opened.However, the stent was warped, and the physician considered that the shape may influence the ability to attach to the vessel wall.The pipeline was retrieved and withdrawn from the patient's body, and a new stent was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use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.Ancillary devices include a terumo sheath, navien guide catheter, and marksman microcatheter.

• 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: 9621704
• Report Number: 2029214-2020-00065
• Device Sequence Number: 11381439
• Product Code: OUT
• UDI-Device Identifier: 00847536016569
• UDI-Public: 00847536016569
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2020

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: 08/13/2022
• Device Model Number: PED-450-35
• Device Catalogue Number: PED-450-35
• Device Lot Number: A882138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2020
• Initial Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR