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

Model Number	BA22-80/I16-40
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	05/26/2017
Type of Reportable Event	Serious Injury
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.Devices remain implanted in the patient.
Event or Problem Description
A patient previously implanted with afx devices to repair an abdominal aortic aneurysm returned for a physician visit.The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.The physician identified aneurysm sac growth and potential type 3 endoleak.The patient was transferred to another hospital where an angiogram was completed.Angiogram showed a type 2 endoleak or possible endotension.The physician identified 2 lumbar arteries that may be communicating with the aneurysm sac and plans to ligate the arteries.To date, the case status and patient condition have not been reported.
Additional Manufacturer Narrative
Based on the clinical assessment for this event, the most likely cause of the compromised stent graft integrity was found to be anatomy related.A clinical assessment showed that the device did not contribute to this event.Procedure-related circumstances were found to have contributed to this event.Anatomical factors such as the dissected, calcified blood lumen were found to have likely contributed to the event.No user-related issues were found, although product use was off-label due to the unrelated, short neck anatomy.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.The type 3b endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at (b)(4).Since the corrective actions were implemented, the type 3b endoleak events reported for afx devices has been reduced to (b)(4).

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6665606
• Report Number: 2031527-2017-00326
• Device Sequence Number: 19347674
• Product Code: MIH
• UDI-Device Identifier: 00818009010124
• UDI-Public: (01)00818009010124(17)180112
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2018
• Device Model Number: BA22-80/I16-40
• Device Lot Number: 1310339-027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 09/11/2017
• 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
• Patient Age: 80 YR