MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; SUPRARENAL AORTA UNI-ILIAC

Model Number A34-34/C100-O20

Device Problems Failure To Adhere Or Bond (1031); Premature Activation (1484)

Patient Problem Failure of Implant (1924)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

It was reported the patient had an initial procedure on (b)(6) 2012 with a bifurcated device and two suprarenal aortic extensions.On (b)(6) 2016 computed tomography revealed a type 3a device separation with aneurysm growth.On (b)(6) 2016 the physician elected to repair the endoleak by implanting two infrarenal extensions which sealed the endoleak.Patient is stable.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTA UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 5410804
• MDR Text Key: 37487683
• Report Number: 2031527-2016-00034
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2016

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: 04/30/2015
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1044103-030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR