MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-80/I20-40

Device Problems Collapse (1099); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During the initial procedure, while deploying the main body it was discovered through angio that the main body was placed above the renals and the iliac limbs were much higher compared to the original position.The physician attempted to snare the limbs to place it back in the iliac but the limbs collapse.A medtronic aortomonoiliac was placed and the physician performed a femoro-femora bypass to successfully resolve the issue.Patient is reported to be doing well.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7119766
• MDR Text Key: 95004176
• Report Number: 2031527-2017-00672
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009012210
• UDI-Public: (01)00818009012210(17)200327
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/27/2020
• Device Model Number: BA25-80/I20-40
• Device Lot Number: 1668747009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other