MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-80/I20-40
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this 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.Device remains implanted.
Event or Problem Description
During the initial implantation of the an afx2 bifurcated stent graft, an intraoperative 3b endoleak and deployment issue was reported.The patient had coiling and a non- endologix (gore/ excluder leg) stent implanted in the right common iliac artery first.This is outside the outside the indications of use due to the use of non- endologix devices.The afx2 bifurcated stent graft was then implanted using the left access.When deploying the contralateral limb of the bifurcated stent graft it appears that it did not fully expand.An angiogram after balloon touch-up on both the afx2 bifurcated stent graft and non-endologix (excluder leg) stent showed an endoleak.An afx limb stent graft was added and another angiography was performed.As the volume of endoleak was decreased, the procedure was completed.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The reported difficulty to deploy the contralateral limb was confirmed.The most likely cause for the difficulty in deployment was due to the 47 degree angle of the right common iliac artery to the bifurcation.The reported intraoperative type iiib endoleak was also confirmed.The intraoperative type iiib endoleak was likely due to the off label right common iliac artery diameter of 25.9mm (should be 10-23mm) as well as the concomitant product use of non endologix stents.Additionally, the absence of an aortic aneurysm is also an off label condition.Procedure related harms for this complaint could not be determined.The final patient status was not reported.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device remains implanted; therefore, no device evaluation was completed.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: d4: lot expiration date/udi# - updated.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 9777768
• Report Number: 2031527-2020-00082
• Device Sequence Number: 14081336
• Product Code: MIH
• UDI-Device Identifier: 00818009014955
• UDI-Public: (01)00818009014955(17)200305
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: 03/05/2021
• Device Model Number: BEA22-80/I20-40
• Device Lot Number: 2207421010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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: COILS; EXCLUDER LEG (16-12/10CM), GORE (NON- ENDOLOGIX); LIMB STENT GRAFT, LOT 1765865005
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR