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

Model Number	BA25-70/I16-30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/04/2019
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.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.
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 4.5 years post initial procedure, sac growth with an endoleak of indeterminate origin was reported.An intervention was completed.The physician elected to reline the original implanted devices with an afx2 bifurcated stent graft and a vela infrarenal stent graft to treat this event.The patient's status was not provided but there have been no additional patient sequelae reported.
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 unable to find substantial evidence to support the reported event of the indeterminate endoleak and sac growth based on medical records and imaging available to review.The medical records and imaging received was from 2014 for when the device was implanted.Medical records for the event that occurred in 2019, were requested but were denied due to patient¿s authorization needed.As such, procedure related harms, event determination, off label conditions, related patient harms and patient disposition 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.Device iteration is afx with duraply.Corrections: g1,2: contact office- name has been updated h6: result code: remove code 3233 h6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9136958
• Report Number: 2031527-2019-00443
• Device Sequence Number: 3046725
• Product Code: MIH
• UDI-Device Identifier: 00818009010100
• UDI-Public: (01)00818009010100(17)170627
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 06/27/2017
• Device Model Number: BA25-70/I16-30
• Device Lot Number: 1263565052
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 06/03/2020
• 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 SUPRARENAL, LOT 1252457024
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR