MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-90/I16-30

Device Problems Misconnection (1399); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

Endologix will continue to investigate the reported event.The patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.

Event Description

An afx2 bifurcated stent graft and an afx vela suprarenal were implanted to treat an abdominal aortic aneurysm (aaa).Approximately two (2) years post op, a routine follow-up ct identified component separation.The patient is being monitored.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported type iiia endoleak between the bifurcated and suprarenal extension devices with a secondary endovascular procedure.The event is most likely anatomy-related due to the aortic remodeling observed on 24-month computed tomography (ct) images and compared with the pre-ct.Procedure-related harms for this event could not be determined.The final patient status was reported as being stable.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Device iteration is afx2.

Event Description

Additional information received confirming that the physician elected to treat the patient by implanting an infrarenal and additional suprarenal afx devices on (b)(6) 2019.The patient is reportedly doing well and the component separation was resolved.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8546633
• MDR Text Key: 142968749
• Report Number: 2031527-2019-00212
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Public: (01)0081800901486317)171109
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2017
• Device Model Number: BEA25-90/I16-30
• Device Lot Number: 1613714010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL (LN 1624701010); AFX VELA SUPRARENAL (LN 1624701010)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 81 YR