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

Model Number BEA25-90/I20-30

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Not Applicable (3189)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx2.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, the patient presented with aneurysm enlargement (increase by 6mm).The patient will return for ultrasound/duplex in three (3) months.As of date, there have been no additional patient sequelae reported.

Manufacturer Narrative

During the investigation of this event, that the sac growth increased by 6mm event was refuted, rather the sac dilation is 4mm since the implant procedure (5mm or more is considered a sac growth).There is no device malfunction.The final patient status is reported being monitored.The event is anatomy related and not related to a device failure therefore this event is no longer reportable.A complaint is not warranted since there is no alleged deficiency related to identity, quality, durability, reliability, safety, effectiveness, or performance of the device.Corrections: h6: patient code: remove code 1708 h6: device code: remove code 3190 h6: result code: remove code 3233.H6: conclusion code: remove code 11.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately three (3) years post initial procedure, the patient presented with aneurysm enlargement (increase by 6mm).The patient will return for ultrasound/duplex in three (3) months.As of date, there have been no additional patient sequelae reported.Additional information: during the investigation of this event, that the sac growth increased by 6mm event was refuted, rather the sac dilation is 4mm since the implant procedure (5mm or more is considered a sac growth).There is no device malfunction.The final patient status is reported being monitored.The event is anatomy related and not related to a device failure therefore this event is no longer reportable.

• Brand Name: AFX2
• Type of Device: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9292688
• MDR Text Key: 182445479
• Report Number: 2031527-2019-00505
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014825
• UDI-Public: (01)00818009014825(17)170316
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2017
• Device Model Number: BEA25-90/I20-30
• Device Lot Number: 1355710-013
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL: 1484358-028
• Patient Outcome(s): Other
• Patient Age: 67 YR