MAUDE Adverse Event Report: ENDOLOGIX AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA28-110/I16-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation and remains implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately four (4) months post initial procedure, the physician elected to treat the patient for an unknown device failure by implanting a suprarenal afx and three (3) infrarenal afx devices on (b)(6) 2019.There is limited information available for the initial report to this event.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Correction: as this event is not longer a reportable complaint please remove all information provide in the initial report.
Event or Problem Description
During the course of the investigation of this event, it was discovered that there was no device failure there is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device therefore this is not longer a reportable complaint.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8484403
• Report Number: 2031527-2019-00164
• Device Sequence Number: 1315063
• Product Code: MIH
• UDI-Device Identifier: 00818009014580
• UDI-Public: (01)00818009014580(17)190517
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 05/17/2019
• Device Model Number: BEA28-110/I16-30
• Device Lot Number: 1934465-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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