MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-80/I13-40

Device Problems Collapse (1099); Leak/Splash (1354); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 06/01/2018

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 an afx to treat an abdominal aortic aneurysm.6 years after the original implant the patient was found to have a possible type 1a or type 3 endoleak.The physician performed a secondary procedure on (b)(6) 2018 in an attempt to reline the afx graft.The physician found partial component separation with a severe angle mid graft.The physician was unable to complete the procedure due to patient anatomical difficulties.The physician decided to stop the procedure and has made the decision to repair the graft at a later date with an open procedure.Currently, there has been no further reports of negative patient sequelae.

Manufacturer Narrative

Clinical assessment was performed based off the provided medical records.The reported type iiia endoleak of the aortic components with buckling of the proximal extension is confirmed.The attempted unsuccessful secondary endovascular procedure on (b)(6) 2019 is confirmed.The final patient status is post open repair procedure.In addition, clinical assessment determined that there was evidence to reasonable suggest stent cage dilation of the main body (38%) and the proximal extension (31%) occurred that was not included in the event as reported.The dilations were discovered on (b)(6), 2019 during review of the 70 month post implant ct scan.The event is most likely anatomy related as the severe aortic neck angle of 82° likely contributed to the type iiia endoleak and resultant buckling of the proximal extension, most likely due to aortic remodeling.The pre implant aortic angle was not available, however considering the 70 month time span from implant to event it was most likely due to the aortic remodeling.Procedure related harms for this complaint could not be determined.The review of manufacturing lot confirmed all devices met specifications prior to release.No additional investigations of this reported complaint are planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.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.Device codes - 1354 removed, correction.Conclusion codes - 92 removed, correction.

Event Description

An afx bifurcated stent graft and an afx suprarenal aortic extension were implanted to treat an abdominal aortic aneurysm.Approximately, six (6) years post procedure a possible type ia or type 3 endoleak was identified.Re-intervention was performed; however, it was unsuccessful.The physician reported that there was partial component separation (type 3a endoleak) with a severe angle mid graft and another angle in the proximal neck.The physician was unable to complete the procedure.The physician was unable to keep the wires in the true lumen of the graft.The angles caused the struts of the graft to stick into the central lumen of the graft and the wires could not avoid them.A brachial approach was attempted; however, true lumen access was not possible.The physician decided to stop the procedure and the graft was explanted on a later date at a different hospital.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7638419
• MDR Text Key: 112349270
• Report Number: 2031527-2018-00561
• 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: 06/25/2018

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: 10/31/2012
• Device Model Number: BA25-80/I13-40
• Device Catalogue Number: F00410
• Device Lot Number: W11-5781-008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 04/05/2019
• 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 1040959-002; SUPRARENAL AORTIC EXTENSION, LOT 1040959-002
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR