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

Model Number	BEA25-120/I20-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is anticipated that the device remains in the patient.If additional information pertinent to the event is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2016, the patient was initially implanted with an afx2 bifurcated stent graft, and afx vela infrarenal.On (b)(6) 2018, a secondary procedure was performed for an unknown reason and an afx vela suprarenal was implanted.No additional event or patient information is available.
Additional Manufacturer Narrative
Based on clinical assessment evaluation, it was determined that the secondary procedure was to treat a type ii endoleak.Type ii endoleak are anatomy related; therefore the was no device failure and this should not have been captured as a complaint.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7443812
• Report Number: 2031527-2018-00335
• Device Sequence Number: 1963112
• Product Code: MIH
• UDI-Device Identifier: 00818009014665
• UDI-Public: (01)00818009014665(17)170419
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: Physician
• Device Expiration Date: 04/19/2017
• Device Model Number: BEA25-120/I20-40
• Device Lot Number: 1355285003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA INFRARENAL (LN 1252165026)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR