MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-80/I16-40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/12/2015
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).Six (6) days post initial procedure, a secondary procedure was completed for unknown reason.Another infrarenal stent graft extension and two (2) limb stent grafts were implanted.No further information is currently available regarding this intervention.
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 events of a type 1 endoleak of indeterminate origin and a secondary procedure.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records and imaging available for review.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 afx with duraply corrections: g1,2: contact office- name has been updated h6: result code: remove code 3221 h6: conclusion code: remove code 11.
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).Six (6) days post initial procedure, a secondary procedure was completed for unknown reason.Another infrarenal stent graft extension and two (2) limb stent grafts were implanted.No further information is currently available regarding this intervention.Additional information: the reported secondary procedure was due to a type 1 endoleak of indeterminate origin.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8525449
• Report Number: 2031527-2019-00195
• Device Sequence Number: 1885077
• Product Code: MIH
• UDI-Device Identifier: 00818009010025
• UDI-Public: (01)00818009010025(17)171018
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2015

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: 10/18/2017
• Device Model Number: BA28-80/I16-40
• Device Lot Number: 1284936-025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2015
• Supplement Date Received by Manufacturer: 06/12/2015
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 04/22/2020
• 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: VELA INFRARENAL, LOT 1252525011
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR