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

Model Number BA25-90/I16-30

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Stretched (1601); Unintended Movement (3026)

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

Event Date 03/08/2018

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.

Event Description

An afx bifurcated and a suprarenal extension was implanted to treat an abdominal aortic aneurysm.The 5 year follow-up showed the presence of an endoleak and aneurysm enlargement; however, the type of endoleak cannot be determined at this time but the patient had minimal overlap and proximal neck dilation with dilation of the proximal cuff.Patient is currently reported to be doing well.The physician will evaluation the patient for further treatment.

Manufacturer Narrative

Based on the information received, clinical evaluation confirmed the reported aneurysm enlargement.Clinical evaluation was unable to confirm the reported patient status of doing well and being on surveillance.Additionally, clinical evaluation found a type iiia -aortic endoleak with complete component separation.The most likely cause of the proximal and mid-aortic (complete component separation) loss of seal was the anterior remodeling of the aorta; however, a definitive root cause cannot be determined.There was no evidence of a secondary procedure and the patient status is unknown.Reportedly, the patient will be on surveillance.There are no further reports of negative patient sequelae.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot 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.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7403429
• MDR Text Key: 104591739
• Report Number: 2031527-2018-00219
• 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: 03/08/2018

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: Physician
• Device Expiration Date: 01/31/2013
• Device Model Number: BA25-90/I16-30
• Device Lot Number: 1031315-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 05/22/2018
• Supplement Dates FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2012
• 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-LOT: W11-4192-016
• Patient Outcome(s): Other
• Patient Age: 79 YR