MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA22-80/I13-40

Device Problems Material Puncture/Hole (1504); Product Quality Problem (1506); Stretched (1601); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately seven (7) years post initial procedure, two (2) type iiib endoleaks were detected during routine ct follow-up.The physician elected to non-emergently treat the patient by relining with ovation ix (main body and two (2) iliac limbs) devices on (b)(6) 2019.The procedure was completed successfully and the patient was discharged the following day.There have been no additional patient sequelae reported.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported event of a type iiib endoleak of the proximal extension and bifurcated device.This event is most likely device-related due to the use of strata material.Procedure-related harms for this event could not be determined.The final patient status was reported as well post a successful secondary ovation reline, confirmed by the one-month post-secondary procedure ct scan.The clinical assessment also determined that there was evidence to reasonably suggest stent cage dilation of the bifurcated device (56%) and the proximal extension (44%) with a type iiia endoleak of the aortic components occurred that was not included in the event as reported; these events were discovered during review of the 83-month post-implant ct scan.The manufacturing lot review confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.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.

Event Description

Additional information received per clinical assessment confirming that a type iiia endoleak and stent cage dilation of both the bifurcated device (56%) and the proximal extension (44%) were present at the time of the reported event.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8449289
• MDR Text Key: 139746783
• Report Number: 2031527-2019-00133
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: BA22-80/I13-40
• Device Lot Number: W11-5983-010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0008-2019
• Patient Sequence Number: 1
• Treatment: AFX-SUPRARENAL AORTIC EXTENSION:1030499-010; AFX-SUPRARENAL AORTIC EXTENSION:1030499-010
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR