MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number BA28-110/I20-30

Device Problems Hole In Material (1293); Leak/Splash (1354); Stretched (1601)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; endoleak type ia, suprarenal cuff migration (report#:2031527-2017-00484).Additionally there was evidence to reasonably support the following observations; sac enlarge javascript:spellcheck('addtl mfg narrative')ment, endoleak type ii, stent case dilation and endoleak type iiib of the main body.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent graft integrity (stretch [36%] and breached fabric) of the main body stent was the progressive stent remodeling caused by a tortuous proximal and distal aorta in combination with aggressive angioplasty (anatomy and unintentional user-error) at implant.Cautionary and off label product use conditions, and procedure- related harms could not be determined due the lack of medical information surrounding the implant and event procedures.Associated clinical harms for this event included: type iiib endoleak of the main body stent.There have been no further negative patient sequelae for this event.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot 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.

Event Description

It was reported that during routine follow-up a type 1a endoleak was observed; specifically the aortic extension had moved down.The patient was asymptomatic at the time.The physician elected to treat the type 1a endoleak with a vela infrarenal and two vela suprarenal devices (reported in report# 2031527-2017-00484).During clinical evaluation completed on (b)(6) 2017, it was discovered that the patient also had an endoleak type iiib of the main body stent.At the completion of the secondary procedure the patient was reported as doing well.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7108341
• MDR Text Key: 94514956
• Report Number: 2031527-2017-00666
• 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: 12/05/2017

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: Paramedic
• Device Expiration Date: 02/18/2018
• Device Model Number: BA28-110/I20-30
• Device Lot Number: 1252483034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2018
• 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-LIMB GRAFT-LOT: 1353488-015; VELA SUPRARENAL-LOT: 1252483-034
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR