MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA28-110/I20-30
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/22/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported the patient had an initial procedure with a bifurcated stent and an infrarenal aortic extension.An in-house clinical review of patient imaging identified the completion of a subsequent endovascular procedure where the physician implanted a suprarenal aortic extension as well as a limb extension to resolve an unknown issue.
Additional Manufacturer Narrative
Clinical evaluation: at the completion of the clinical evaluation, based on the information received, the following were confirmed: secondary procedure to place a suprarenal cuff and right iliac limb extensions for the endoleak type ia and type ib of the right limb.Additionally there was evidence to reasonably support the following observations: endoleak type ia after suprarenal cuff placement that was treated with a non-endologix balloon expandable stent and angioplasty.Root cause: based on the information available the root cause of the reported event cannot be determined definitively.The event device was not returned for further evaluation.Clinical found evidence to reasonably suggest the following contributing factors to the reported event: off label, low placement of the initial cuff, and infrarenal neck angle.
Event or Problem Description
Additional patient records received to date indicate that a persistent type 1a endoleak was resolved by a tertiary procedure during which a non-endologix stent was implanted.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6429553
• Report Number: 2031527-2017-00120
• Device Sequence Number: 18970569
• Product Code: MIH
• UDI-Device Identifier: 00818009014214
• UDI-Public: (01)00818009014214(17)171014
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2017
• Device Model Number: BA28-110/I20-30
• Device Lot Number: 1283284-024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: 02/22/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 07/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFRARENAL AORTIC EXTENSION- 1249730-010
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR