MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-70/I20-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Endologix will continue to investigate the reported event.The patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.
Event or Problem Description
An afx2 bifurcated stent graft and an afx suprarenal aortic extension were implanted to treat an abdominal aortic aneurysm (aaa).Reportedly, this was a thrombotic aneurysm case and the inner diameter of aneurysm was narrower prior to evar.The index procedure was successfully completed.Approximately two (2) months post op, the routine follow-up ct identified thrombosis throughout the main body and the vela suprarenal extension.The patient is being monitored.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported events of thrombosis of the stent graft.The final patient status was reported to be under surveillance.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records/ images available for review.The contributing factors for the mild thrombosis within the stent graft could not be identified due to lack of medical records.However, the peripheral vascular blood flow is not compromised from the mild thrombosis within graft.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.Device iteration is afx2.Corrections: g1,2: contact office- name" updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8537467
• Report Number: 2031527-2019-00204
• Device Sequence Number: 2431680
• Product Code: MIH
• UDI-Device Identifier: 00818009014566
• UDI-Public: (01)00818009014566(17)190720
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: 07/20/2019
• Device Model Number: BEA28-70/I20-40
• Device Lot Number: 1958234007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 03/04/2020
• 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 SUPRARENAL (LN 1967723006); AFX VELA SUPRARENAL (LN 1967723006)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR