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

Model Number	PED-450-20
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
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 pipeline failed to open due to manipulation by the healthcare provider (hcp).The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 9mm and a 4mm neck diameter, and a landing zone of 3.8x4.1mm.It was noted the patient's vessel tortuosity was normal.It was reported that the pipeline appeared to be twisted after being overworked by the healthcare provider (hcp) being proctored by the main physician overseeing them.As a result, the pipeline failed to open in the middle section, but more than 50% had been deployed.It was noted the pipeline was in a proximal part of a bend.The device was re-sheathed less than or equal to two times, and no additional steps or other devices were required to open the pipeline.The device was re-sheathed, and removed from the patient.A new pipeline was introduced and deployed with no issue to complete the procedure.After the case, the main physician stated that it was not a device problem and that it should not have been manipulated the way it was and it would not have been an issue.Angiographic results post-procedure were good.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 shuttle guidecatheter, phenom 27 microcatheter, and anahi chikai guidewire.

• 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: 9575709
• Report Number: 2029214-2020-00027
• Device Sequence Number: 2578794
• Product Code: OUT
• UDI-Device Identifier: 00836462015548
• UDI-Public: 00836462015548
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/10/2020

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 Model Number: PED-450-20
• Device Catalogue Number: PED-450-20
• Device Lot Number: A651269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1