MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A34-34/C100V
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, a type 1a endoleak was identified with computerized tomography (ct) scan.An intervention is being discussed and the patient is reported to be doing well.
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.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several attempts were made to obtain medical records and images but only a discharge summary was received with no medical information noted.Discharge instructions only.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.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 an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately three (3) years post initial procedure, a type 1a endoleak was identified with computerized tomography (ct) scan.A intervention is being discussed and the patient is reported to be doing well.Additional information received; an intervention was completed.The physician elected to implant a suprarenal stent graft extension to treat this event.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8621457
• Report Number: 2031527-2019-00241
• Device Sequence Number: 2494992
• Product Code: MIH
• UDI-Device Identifier: 00818009013552
• UDI-Public: (01)00818009013552(17)190201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 04/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: A34-34/C100V
• Device Lot Number: 1252541-012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 04/27/2020
• 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: BIFURCATED STENT GRAFT, LOT 1282171021; BIFURCATED STENT GRAFT, LOT 1282171021
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 65 YR