MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-90/I16-30

Device Problem Collapse (1099)

Patient Problems Failure of Implant (1924); Claudication (2550)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

The lot history records related to the subject device referenced in this complaint record were reviewed for potential contributing factors for the failure mode(s) described in this event.A review of the device quality records showed that the device(s) demonstrated compliance to established procedures and specifications at the time of manufacture.

Event Description

The patient was initially treated with the afx2 abdominal aortic aneurysm stent.Approximately fifteen (15) months post initial procedure, the patient complains of a history of claudication and ct imaging showed evidence of possible iliac kinking.A secondary intervention was completed where a bare metal stent was placed successfully opening the lumen.As of the date of this report, there have been no additional patient sequelae reported.

Manufacturer Narrative

A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging; requests were made and no response was received.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.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.

• Brand Name: AFX2
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8104360
• MDR Text Key: 128383694
• Report Number: 2031527-2018-00889
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014597
• UDI-Public: (01)00818009014597(17)171219
• 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
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

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: Health Professional
• Device Expiration Date: 12/19/2017
• Device Model Number: BEA28-90/I16-30
• Device Catalogue Number: BEA28-90/I16-30
• Device Lot Number: 1628780R014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VELA SUPRARENAL - 1671547-001
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR