MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-90/I16-30

Device Problems Material Puncture/Hole (1504); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Component or Accessory Incompatibility (2897)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 05/28/2020

Event Type  Injury  

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 strata.

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately 8.5 years post initial procedure, a type 3b endoleak with sac growth was identified.Physician elected to resolve the leak with a non-endologix device (medtronic endurant graft).Endoleak resolved and patient is doing well.

Manufacturer Narrative

Additional clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that type iiib endoleak of the distal bifurcated stent body event is confirmed.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.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 strata.Correction: b1: adverse event\product problem.

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, the current reported 3b endoleak is unconfirmed due to a lack of relevant medical imaging surrounding the reported event however a type 3b endoleak of the distal bifurcated stent graft occurred on the 4 month post index computed tomography (ct) scan.The final patient status was reported to be doing well following a successful secondary endovascular procedure with non endologix stents.The distal type 3b endoleak was likely related to the concomitant product use of a non -endologix stent in the left common iliac artery, the left common iliac anatomy was off label (91 degree angulation to bifurcation)- should be less than or equal to 90 degrees and the use of strata material.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.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 strata.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10200660
• MDR Text Key: 201027804
• Report Number: 2031527-2020-00182
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: BA28-90/I16-30
• Device Lot Number: W11-4272-003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 05/30/2020; 10/09/2020
• Supplement Dates FDA Received: 08/18/2020; 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: SUPRARENAL AORTIC EXTENSION. LOT#W11-3168-024
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR