MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C100-O20

Device Problems Stretched (1601); Material Integrity Problem (2978); Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 12/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately five (5) years post initial procedure, a type 1a endoleak was identified.A secondary procedure was completed.The physician elected to implant a non- endolgix stent (medtronic) to treat the reported the event.As of the date of this report, there have been no additional patient sequelae reported.

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 reported events of a type 1a endoleak and an additional finding of crown separation.This event is most likely device related due to the crown separation.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.Correction: conclusion code: remove code 11.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8265460
• MDR Text Key: 133708311
• Report Number: 2031527-2019-00054
• Device Sequence Number: 1
• Product Code: MIH
• 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: 12/23/2018

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: 10/31/2015
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1026333R-009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2018
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 02/01/2019
• Supplement Dates FDA Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: BIFURCATED STENT GRAFT, LOT 1053295-011; BIFURCATED STENT GRAFT, LOT 1053295-011
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR