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

Model Number BA28-90/I20-30

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 11/15/2017

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.

Event Description

The patient was implanted with an afx bifurcated stent graft and suprarenal aortic extension on (b)(6) 2013.On a later date, the physician did not observe any obvious endoleaks but wanted to reline the afx system due to the aneurysm growing.The secondary procedure was completed on (b)(6) 2017 and the physician relined successfully with an afx2 bifurcated stent graft and vela suprarenal.The patient was in stable condition pre, peri, and post-operative and there were no devices explanted.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: the indeterminate endoleak and sac growth complaint is confirmed.The complaint is most likely device related; use of the strata material is most likely the contributing factors for this event.In addition, main body appeared dilated about 40mm.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be stable.The manufacturing lot review confirmed all devices met specifications prior to release.This complaint is not capa eligible at this time.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7445928
• MDR Text Key: 106007451
• Report Number: 2031527-2018-00194
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2014
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1101187-016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-SUPRARENAL AORTIC EXTENSION - LOT 1047256-030; AFX-SUPRARENAL AORTIC EXTENSION - LOT 1047256-030
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR