MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-90/I16-30

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Leak/Splash (1354); Unintended Movement (3026)

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

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Primary procedure performed on (b)(6) 2015.A afx bifurcated stent and afx vela suprarenal were implanted.Follow-up computerized tomography was done on an unknown date and showed that there was a short overlap of devices and expanding aaa, but the patient did not come in for repair.There is now a endoleak 3a and separation of devices requiring a bridge device.Due to the enlargement in the neck, dr.(b)(6) plans to electively bridge with a thoracic device.Patient is doing well currently.No additional event or patient information is available at this time.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7572602
• MDR Text Key: 110165343
• Report Number: 2031527-2018-00511
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 0081009010247
• UDI-Public: (01)0081009010247(17)171013
• 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: 05/17/2018

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: 10/13/2017
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1283107006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2014
• 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 VELA SUPRARENAL (LN 1278300002)
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR