MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; VELA SUPRARENAL

Model Number	A28-28/C95-O20V
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is anticipated that the device remains in the patient.If additional information pertinent to the event is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2015, the patient was initially implanted with a bifurcated stent graft, and a vela suprarenal.On (b)(6) 2016, a secondary procedure was performed to treat an endoleak at an undetermined location.The patient was implanted with an additional vela suprarenal.No additional event or patient information is available.
Additional Manufacturer Narrative
Based on the information received, clinical evaluation confirmed the reported secondary endovascular procedure.Clinical evaluation was unable to confirm the reported undetermined endoleak.Additionally, clinical evaluation found that the suprarenal cuff had migrated (~2cm).The most likely cause of the suprarenal cuff migration was the lateral movement and/or aortic remodeling.Procedure related harms and final patient disposition could not be ascertained due to the lack of medical information surrounding the secondary endovascular procedure.To date there has been no reports of further negative patient sequalae.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot 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.Common device name - correction, model number - correction, lot number - correction, expiration date - correction, unique identifier number - correction, concomitant medical products - correction, device manufacturer date - correction, device code - correction.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7444321
• Report Number: 2031527-2018-00281
• Device Sequence Number: 1950419
• Product Code: MIH
• UDI-Device Identifier: 00818009010032
• UDI-Public: (01)00818009010032(17)170915
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2016

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: Physician
• Device Expiration Date: 03/06/2018
• Device Model Number: A28-28/C95-O20V
• Device Lot Number: 1252413044
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/31/2016
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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: AFX VELA SUPRARENAL (LN 1252413044)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR