MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA25-80/I20-40

Device Problems Collapse (1099); Hole In Material (1293); Leak/Splash (1354); Stretched (1601); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 03/10/2017

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

It was reported the patient had an initial procedure with a bifurcated stent and a suprarenal aortic extension.A follow up showed the patient had a type 3b endoleak.A secondary intervention was completed on an unknown date.The repair devices used is also unknown.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based upon the information received, the root cause of the stent kink was likely anatomy related, as there were protruding calcifications in the bifurcation and iliac arteries, and a moderate/severe posterior angulation of the right common iliac artery, which did not allow the stent cage to expand in the aorto-iliac region.Based upon the information received, the root cause of the compromised stent graft integrity and subsequent endoleak type iiib was due to a device failure of the strata graft material.The reported event of a endoleak type iiib of the main body was confirmed, with a secondary endovascular repair with a non-endologix stent.Additionally there was evidence to reasonably support the following observations: non flow limiting stent collapse of the right limb portion of the main body stent, dilation of the stent cage (20%), and aneurysm growth.The final patient disposition at 14 months post implant was known to be stable with aneurysm sac regression and no active endoleak.The review of manufacturing lot records confirmed all devices met specifications prior to release.The event devices were not returned, therefore no physical evaluation was completed.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 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: 6474735
• MDR Text Key: 72174055
• Report Number: 2031527-2017-00153
• 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: 03/10/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: BA25-80/I20-40
• Device Lot Number: 1047049-018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: 03/10/2017
• Supplement Dates FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2013
• 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 AORTIC EXTENSION- 1047273-002
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR