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

Model Number	PED-425-25
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2019
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 while deploying the device, the distal end would not open.The device was resheathed 2 times; however, it would not open.It was noted the proximal part of the device was positioned in a bend.More than 50% of the device had been deployed when it failed to open.There were no additional steps or other devices required to open the device.The physician made the decision to remove the device and use a new one.The device was resheathed and removed with the microcatheter.The patient was undergoing surgery to treat an unruptured, saccular aneurysm at the left ica with a max diameter of 13mm and a neck diameter of 8mm.The distal and proximal landing zones were 4mm and 4.3mm.It was noted the vessel tortuosity was moderate.The post procedure angiographic result was very good.There were no patient symptoms associated with the event.Dapt (dual antiplatelet treatment) was administered.The devices were prepared as indicated in the ifu.

• Brand Name: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8388518
• Report Number: 2029214-2019-00154
• Device Sequence Number: 18910323
• Product Code: OUT
• UDI-Device Identifier: 00847536016231
• UDI-Public: 00847536016231
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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 Expiration Date: 07/08/2021
• Device Model Number: PED-425-25
• Device Catalogue Number: PED-425-25
• Device Lot Number: A672266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1