MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I16-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following event of mild (30-49%) distal stenosis of the abdominal portion of the bifurcated stent graft.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined.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.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, a computerized tomography (ct) scan identified mild distal stenosis of the abdominal portion of the bifurcated stent graft.The patient is being monitored and there have been no additional patient sequelae reported.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8574219
• Report Number: 2031527-2019-00216
• Device Sequence Number: 11231761
• Product Code: MIH
• UDI-Device Identifier: 00818009010018
• UDI-Public: (01)00818009010018(17)181223
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2019

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: 12/23/2018
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 1282510-018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 05/02/2019
• 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: VELA SUPRARENAL, LOT 1441533-007
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR