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

Model Number BA28-120/I20-40

Device Problems Difficult or Delayed Positioning (1157); Hole In Material (1293); Leak/Splash (1354); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2017

Event Type  malfunction  

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.Device remains implanted in the patient.

Event Description

It was reported the physician encountered an issue with the bifurcated stent during the initial implant.Post deployment of the afx device, the contralateral limb remained significantly constrained.In troubleshooting the patient used a balloon to deploy the contra lateral limb.The ballooning of the limb caused a type 3b endoleak, the physician relined the main body to seal the leak.There is no reported injury to the patient.The patient is reported to be in stable condition.

Manufacturer Narrative

Clinical evaluation: due to lack of medical information available the clinical evaluation was unable to find substantial evidence to confirm the following reported events: difficult to deploy, endoleak type iiib of the main body after balloon remedy, and successful main body re-lining.The clinical assessment was based on no patient medical records, and suboptimal patient images.Root cause: based on the information available the root cause of the reported event cannot be definitively determined, although it was reported that the excessive ballooning caused the endoleak type iiib.The device was not returned; therefore, a sample evaluation was not completed.Clinical found evidence to reasonably suggest the following contributing factors to the reported event: off label use and patient anatomy.Corrected data: (b)(4).

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 6474429
• MDR Text Key: 72188515
• Report Number: 2031527-2017-00141
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2018
• Device Model Number: BA28-120/I20-40
• Device Lot Number: 1370955-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• 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 Age: 57 YR