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

Model Number	PED-250-16
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2019
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 information that the pipeline was discovered to have migrated approximately 15mm six months post successful embolization procedure.There were no patient symptoms associated with the event and the physician is choosing not to retreat the patient at this time.It was noted that the device was sized appropriately at the time of the initial implant, even though the procedure was off label (implanting in acom).Also, some side branches were covered by the pipeline in the a3 segment.The patient was undergoing embolization treatment of an unruptured fusiform aneurysm measuring 4mm x 4mm located in the anterior communicating artery: a2-a3 junction.The distal and proximal landing zone were unknown.The patient¿s vasculature was moderate in tortuosity.Patient was on dual antiplatelet therapy.

• 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: 8650126
• Report Number: 2029214-2019-00489
• Device Sequence Number: 19365478
• Product Code: OUT
• UDI-Device Identifier: 00847536014435
• UDI-Public: 00847536014435
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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: 04/16/2021
• Device Model Number: PED-250-16
• Device Catalogue Number: PED-250-16
• Device Lot Number: A630255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR