MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-110/I16-30
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190); Separation Problem (4043)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	09/07/2019
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 afx2".
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, the patient presented emergently with a ruptured aneurysm.A type 3a endoleak was separation between the bifurcated stent graft and a suprarenal stent graft extension was identified.The physician elected to treat the patient by relining with a non-endologix (gore) device.The re-intervention was successful.As of date, 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.A clinical assessment confirmed, the urgent event of a ruptured aorta, a type iiia aortic endoleak with complete component separation, and a secondary endovascular procedure with non-endologix implants.The type 3a endoleak is most likely anatomy related due to aortic remodeling.No aortic angle was observed at 1month post implant, 104° aortic angle was present at 39month post implant.The neck angle should be less than 60°.The rupture was likely due to the type iiia endoleak.Procedure related harms for this event could not be determined.The final patient status was reported being stable.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 afx2" corrections: g1,2: contact office- name has been updated h6 device code remove 3190 h6: result code: remove code 3233 h6: conclusion code: remove code 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9195168
• Report Number: 2031527-2019-00460
• Device Sequence Number: 2599436
• Product Code: MIH
• UDI-Device Identifier: 00818009014856
• UDI-Public: (01)00818009014856(17)170420
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: 04/20/2017
• Device Model Number: BEA25-110/I16-30
• Device Lot Number: 1356863-020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 06/07/2020
• 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-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELA SUPRARENAL, LOT# 1252409-005
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR