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

Model Number	PED-450-35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	01/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Thrombus is a known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that pipeline flex device was intended to be delivered from the m1 into the ica, but the deployed the device into a branch off of the m1.The device was placed, and the cases ended.1 hr later the patient was brought back to the lab with a thrombus distal to adjacent.The patient was given integrillin and is still on integrillin drip.The pipeline device covered the aneurysm but jailed off the m1-m2.Very sluggish flow and was put on integrillin drip and transferred to patient¿s room.The patient is currently doing well.The devices were prepared and used per the instructions for use (ifu).Ancillary devices: 6fr shuttle, navine 058 115, phenom 027, asahi 10.This event occurred during the treatment of a supraclinoid, right, saccular ica aneurysm.The max diameter was 18mm and the neck was 8mm.The distal landing zone was 2mm and the proximal was 4.5mm.The vessel anatomy was moderate in tortuosity.

• 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: 9555215
• Report Number: 2029214-2020-00012
• Device Sequence Number: 16995058
• Product Code: OUT
• UDI-Device Identifier: 00836462015876
• UDI-Public: 00836462015876
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PED-450-35
• Device Lot Number: A742385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention