MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA28-100/I16-40

Device Problems Collapse (1099); Hole In Material (1293); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 01/09/2017

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 on (b)(6) 2013 with a bifurcated stent and suprarenal aortic extension.A follow up computed tomography (ct) showed a type 3b endoleak.On (b)(6) 2017 the physician elected to implant a non-endologix device to reline the original main body device.During the procedure the physician was able to confirm a type 3b endoleak at the distal portion of the main body stent.The patient was in stable condition following the procedure and there have been no additional adverse events reported for this patient.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm a type 3b endoleak including a collapse of the main body stent.The clinical evaluation additionally identified the following potential contributing factors to the reported event; an increase in the angulation of the infrarenal aorta.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: 6312963
• MDR Text Key: 66859394
• Report Number: 2031527-2017-00057
• 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: 01/09/2017

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: 08/31/2016
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1053305-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2013
• 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: AORTO UNI-ILIAC [INFRARENAL]- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR