MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX

Device Problems Failure To Adhere Or Bond (1031); Bent (1059); Collapse (1099); Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2015, the patient had a secondary procedure due to disease progression, and sac expansion leading to the graft bending, and pulling apart.Reportedly, the physician elected to reline w/an aortic extension due to collapse of the powerlink and continual sac expansion.

Manufacturer Narrative

Based upon the investigation findings, the reported disease progression resulting in the graft bending (collapse) and reduced stent overlap was confirmed.A design or manufacturing root cause for the reported event was not confirmed.The failure appeared to be the result of the disease progression and anatomical remodeling although there was limited information available.

• Brand Name: AFX
• Manufacturer (Section D): ENDOLOGIX, INC.; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 11 studebaker; irvine CA 92618
• Manufacturer Contact: henry ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 5147843
• MDR Text Key: 28359238
• Report Number: 2031527-2015-00403
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/07/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention