MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA25-80/I16-40

Device Problems Failure To Adhere Or Bond (1031); Burst Container or Vessel (1074); Leak/Splash (1354)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Pain (1994); Rupture (2208); No Code Available (3191)

Event Date 12/31/2016

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

It was reported that the patient had an initial procedure on (b)(6) 2013 with a bifurcated and suprarenal aortic extension.Subsequently, on (b)(6) 2016, the patient present to the hospital with a rupture and type 3a endoleak.Physician implanted a non-endologix graft to repair the issue.Patient is in stable condition.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm; a type 3 endoleak between the main body and the proximal extension and an aneurysm rupture.There was also evidence to reasonable suggest the following observations; a type 1a endoleak, aneurysm sac growth, suboptimal overlap between the main body and proximal extension, and dilation of the main body stent.The clinical evaluation additionally identified the following potential contributing factors to the reported event; off label use due to patient anatomy, insufficient overlap between the main body and the proximal extension, and the patient's history of cardiac disease.The review of the manufacturing lot confirmed all devices met specifications prior to release.The event devices remain implanted in the patient and were not available for further evaluation.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event at this time.

• 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: 6284907
• MDR Text Key: 65998591
• Report Number: 2031527-2017-00047
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PO40002
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: BA25-80/I16-40
• Device Lot Number: 1060064-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2012
• 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: SUPRARENAL AORTO UNI-ILIAC - (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR