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

Model Number	BEA25-60/I16-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Rupture (2208)
Date of Event	03/30/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
An afx2 bifurcated was implanted to treat a patient with a tight distal aorta.It was reported that the aorta ruptured and the patient expired approximately 36 hours post implant.The physician stated that he does not believe that the event is related to the afx2 stent graft.It was also noted that the patient has a history of a thoracic aaa.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7520119
• Report Number: 2031527-2018-00451
• Device Sequence Number: 1439057
• Product Code: MIH
• UDI-Device Identifier: 00818009014740
• UDI-Public: (01)00818009014740(17)180405
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 04/13/2018

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: 04/05/2018
• Device Model Number: BEA25-60/I16-40
• Device Lot Number: 1674045002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/16/2018
• 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: Death