MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-100/I16-40

Device Problems Partial Blockage (1065); Collapse (1099)

Patient Problems Failure of Implant (1924); Occlusion (1984); Thrombosis (2100); Claudication (2550); Vascular Dissection (3160)

Event Date 07/08/2014

Event Type  Injury  

Manufacturer Narrative

A clinical assessment, based on the information available, was able to find evidence to support the following reported events: right iliac stent collapse, claudication, near occlusion, dissection, non-endologix stent placement, and deep vein thrombus status post evar procedure.At eight months post-implant, the most likely cause for the right iliac stent collapse was anatomy related.The iliac artery was very tortuous and diseased, with development of a right dissection - a cautionary product use condition.The iliac artery also had a greater than 90° posterior angulation - an off-label anatomy.The inferior stent margin of first the original right iliac portion of the main body stent was sub-optimally positioned whereby the inferior margin was near perpendicular to the vessel wall; an anatomy related issue.There was no user error detected.The pre-existing patient conditions that contributed to near occlusive right iliac included: a new right iliac dissection, concomitant treatment for cancer, and continued use of tobacco products.Associated clinical harms for this device failure included: near complete thrombus occlusion of the right iliac artery, claudication, medical management and endovascular relining on the right iliac artery and stent, as well as a procedure-related deep vein thrombus.The review of manufacturing lot information confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.

Event Description

An afx bifurcated stent graft and suprarenal cuff were implanted to treat an abdominal aortic aneurysm.During a review of patient medical records it was discovered that eight months post-implant a non-endologix stent was placed in the right common iliac artery to repair a stent cage collapse of the bifurcated stent and right iliac.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 6709741
• MDR Text Key: 79887703
• Report Number: 2031527-2017-00358
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1053309-022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AFX SUPRARENAL CUFF (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR