MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A28-28/C75V
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events ofa type 1a endoleak with migration of the cuff (infrarenal extension).The most likely cause of the proximal loss of seal (1a endoleak) was the cuff migration and the cause of the cuff migration could not be determined due to lack of pre-implant medical imaging.Procedure related harms included right access site complication which required a surgical intervention.To date there has been no reports of further negative patient sequalae.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.
Event or Problem Description
At the completion of the clinical assessment on (b)(6) 2018 for a pervious report event (2031527-2018-00379), clinical was able to find substantial evidence to support the following additional findings of 1a endoleak and migration of the infrarenal extension (cuff).This report is for the 1a endoleak and migration of the infrarenal extension (cuff) only.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7627686
• Report Number: 2031527-2018-00556
• Device Sequence Number: 16463067
• Product Code: MIH
• UDI-Device Identifier: 00818009013514
• UDI-Public: (01)00818009013514(17)150206
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2015
• Device Model Number: A28-28/C75V
• Device Lot Number: 1164387-010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR