MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-100/I20-40

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); Pain (1994)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

Based on the information received, clinical evaluation discovered that the patient presented urgently to the er, there was left access site complications from repair procedure performed on (b)(6) 2018, a endoleak type iiia in the right common iliac artery, complete component separation, and sac growth.Clinical evaluation was unable to confirm if there is an additional procedure planned.The most likely cause of the distal loss of seal and implant separation could not be determined due to lack of medical information surrounding the pre-implant and implant procedure.It was suspected that the tortuous iliac anatomy contributed to this event.Since this was a post endovascular repair follow-up findings, repair procedure not yet planned.The patient final disposition could not be determined due to the lack of medical information surrounding this event.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.The secondary procedure was previously captured and reported to the fda under mfr# 2031527-2018-00155.

Event Description

Patient was initially implanted with an afx bifurcated stent, one limb stent, and a vela suprarenal stent.Secondary procedure was performed on (b)(6) 2018, successfully treating an endoleak 1b in the left common iliac artery (lcia).The patient presented to the emergency room on (b)(6) 2018, with post-surgical pain at the left access site.Computerized tomography performed on the same day revealed an endoleak 3a of the right common iliac artery (rcia), complete component separation of the afx bifurcated stent and limb stent, as well as sac growth.At this time, no additional event or patient information is available.

• 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: 7547278
• MDR Text Key: 109355357
• Report Number: 2031527-2018-00499
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014207
• UDI-Public: (01)00818009014207(17)171103
• 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
• Report Date: 05/10/2018

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: 11/03/2017
• Device Model Number: BA28-100/I20-40
• Device Lot Number: 1284146013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR