MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED

Model Number BA25-90/I16-30

Device Problems Failure to Align (2522); Malposition of Device (2616)

Patient Problem Abdominal Pain (1685)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation as they're remaining implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Model# and lot# of other involved device: model#a28-28/c95-020; lot# 1047271-022; dom: (b)(6) 2013; expiration: 04/30/2016.

Event Description

It was reported the patient had a procedure on (b)(6) 2013 with a bifurcated and a suprarenal aortic extension.Reportedly, the patient came into the hospital with an abdominal pain and diagnosis showed the aneurysm grew about two centimeter post implant.An angiogram was performed but did not show an endoleak.The physician elected to reline the main body.No other complications were reported with the patient as a result of the event.

Manufacturer Narrative

Based upon the investigation findings.The reported event is inconclusive.The product remains in the patient with no reported endoleak.It was reported that the patient is in good condition and will have another follow up.A manufacturing record review was performed and the lot met all release criteria with no issues or deviations that would explain the reported event.A design or manufacturing root cause for the reported event could not be determined based on the available information, and overall, the investigation is inconclusive.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX; irvine CA 92618
• Manufacturer Contact: henry ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 5249959
• MDR Text Key: 32198968
• Report Number: 2031527-2015-00463
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

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
• Device Expiration Date: 03/30/2016
• Device Model Number: BA25-90/I16-30
• Device Lot Number: 1047057-041
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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
• Patient Age: 77 YR