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

Model Number	BEA25-80/I20-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft to treat an abdominal aortic aneurysm.Approximately five (5) months post initial implant the physician performed a secondary procedure for an unknown reason.The physician implanted two ovation iliac limbs.No further additional information or patient sequelae has been reported at this time.
Additional Manufacturer Narrative
A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and or imaging; requests were made and no response was received.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Device iteration is afx2.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8453589
• Report Number: 2031527-2019-00142
• Device Sequence Number: 2765561
• Product Code: MIH
• UDI-Device Identifier: 00818009014689
• UDI-Public: (01)00818009014689(17)181120
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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: 11/20/2018
• Device Model Number: BEA25-80/I20-40
• Device Lot Number: 1759588-004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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:1596697-005
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR