MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA28-90/I20-30
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Separation Problem (4043)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/06/2019
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 3.5 years post initial procedure, the patient presented emergently with pain.A computerized tomography (cta) scan identified a type 3a endoleak with insufficient overlap and component separation, sac growth and right side iliac aneurysm.A secondary procedure was completed.The physician elected to implant a suprarenal stent graft extension and a limb stent graft to resolve this event.The patient was discharged with no issues noted.
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 medical images but there was no response.As such, procedure related harms, event determination, off label conditions, related patient harms and patient disposition could not be 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.Device iteration is afx with duraply.Corrections: b1: has been updated.G1,2: contact office- name has been updated.H6: device code: remove code 4043.H6: result code: remove code 3221.H6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8668832
• Report Number: 2031527-2019-00265
• Device Sequence Number: 1968562
• Product Code: MIH
• UDI-Device Identifier: 00818009012630
• UDI-Public: (01)00818009012630(17)170926
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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: 09/26/2017
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1251905-012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0006-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL, LOT 1252485013
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR