MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA25-70/I16-30

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Detachment Of Device Component (1104); Hole In Material (1293); Leak/Splash (1354); Stretched (1601); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices remain implanted in the patient.

Event Description

Patient initially implanted with a bifurcated stent and a suprarenal aortic extension on (b)(6) 2013.On (b)(6) 2016 computed tomography (ct) showed stent fabric on proximal extension and main body stretched past device specifications, a decrease in overlap of the main body and proximal extension, and sac growth with no observed endoleak.The physician elected to reline on (b)(6) 2016 and implanted an additional bifurcated stent and two suprarenal aortic extensions.The patient is stable.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received the following were confirmed; dilation of the suprarenal cuff resulting in an endoleak type iiib, increased sac growth, and stable patient condition.Additionally there was evidence to reasonably support the following observations; endoleak type iiia and complete component separation, placement of a non-endologix in the left external iliac due to mild stenosis, 50% collapse of the proximal portion of the main body stent, and suboptimal position of the suprarenal cuff.The clinical assessment was based on adequate patient medical records, and adequate patient images.Based on the information available the root cause of the reported event is unknown.Devices was not returned and sample evaluation was not completed.Clinical found evidence to reasonably suggest the following contributing factors to the reported event; off label use, extensive stent ballooning, and dilation of the suprarenal stent.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6080641
• MDR Text Key: 59219614
• Report Number: 2031527-2016-00522
• 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,Followup
• Report Date: 10/06/2016

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: 12/31/2015
• Device Model Number: BA25-70/I16-30
• Device Lot Number: 1046779-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 11/04/2016
• Supplement Dates Manufacturer Received: 10/06/2016
• Supplement Dates FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2013
• 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: SUPRARENAL AORTA UNI-ILIAC- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR