MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-80/I20-40

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

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

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted with a bifurcated stent graft, a suprarenal stent graft extension and a limb stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately five (5) years post initial procedure, a type 3a endoleak (limb separation) with sac growth was reported.A secondary procedure was completed.The patient was relined with the ovation aortic sealing system.The patient was reported as doing well post secondary procedure.As of the date of this report, there have been no additional patient sequelae reported.

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 able to find substantial evidence to support the following reported event of a type 3a endoleak with implant separation and sac growth of the left iliac and aorta.Clinical had substantial evidence to support the following additional findings of a type 3b endoleak of the main body and a type 2 endoleak of the left iliac circumflex artery.The type 3b endoleak was mostly likely device related due to the use of strata material.The type 3a endoleak with implant separation was mostly likely user related due to the off- label anatomy.The type 2 endoleak is not a device failure.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 (b)(6) 2014.No additional investigation of this reported event is planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

Event Description

Additional information: at the completion of the clinical assessment on (b)(6) 2019 clinical was able to find substantial evidence to support the following additional findings of type 3b endoleak of the bifurcated stent graft (main body) and a type 2 endoleak of the left iliac circumflex artery.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8205083
• MDR Text Key: 131696636
• Report Number: 2031527-2018-00973
• 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
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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: 04/30/2014
• Device Model Number: BA25-80/I20-40
• Device Lot Number: 1101050-006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIMB STENT GRAFT, LOT 1040041-013; SUPRARENAL EXTENSION, LOT 1050798-023
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR