MAUDE Adverse Event Report: ENDOLOGIX INC. AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number BEA28-90/I20-30

Device Problems Decoupling (1145); Material Separation (1562); Unintended Movement (3026); Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 01/02/2019

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as it remains in the patient.A follow-up report will be submitted upon completion of investigation.

Event Description

An afx2 bifurcated stent graft, an afx suprarenal stent graft extension and an ovation ix extender were implanted to treat an abdominal aortic aneurysm.Approximately 3.5 years post initial procedure the patient was in a traumatic car accident.Post car accident stent separation and a type 3a endoleak were identified.It is probable that the seatbelt caused the device failure.The patient underwent successful re-intervention with excellent results and is doing great.

Manufacturer Narrative

The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events of a type 3a endoleak.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined.The patient was in a motor vehicle accident and this may have contributed to this event.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX2
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8289133
• MDR Text Key: 134488535
• Report Number: 2031527-2019-00066
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)170314
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

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: 03/14/2017
• Device Model Number: BEA28-90/I20-30
• Device Lot Number: 1355102013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 03/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1049-2017
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL (LN 1472869013); OVATION IX EXTENDER (LN FS020416-24); AFX VELA SUPRARENAL (LN 1472869013); OVATION IX EXTENDER (LN FS020416-24)
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR