MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED

Model Number	BA25-110/I16-30
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	02/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.The physician indicated the secondary procedure was not due to a device related failure and most likely caused by a dislodged thrombus from the aneurysm with the wires used in the case.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices remain implanted in the patient.
Event or Problem Description
Patient initially implanted with a bifurcated stent, and a suprarenal aortic extension on (b)(6) 2016.One day post procedure the patient presented with lower extremity ischemia.The physician elected to perform a thromboembolectomy procedure to clear the clot.The patient is in stable condition.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5510667
• Report Number: 2031527-2016-00107
• Device Sequence Number: 10861576
• Product Code: MIH
• UDI-Device Identifier: 00818009012180
• UDI-Public: (01)00818009012180(17)190105
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2016

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 Expiration Date: 01/05/2019
• Device Model Number: BA25-110/I16-30
• Device Lot Number: 1414300-004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2016
• Initial Report FDA Received Date: 03/18/2016
• 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
• Patient Age: 57 YR