MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A34-34/C100V
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient was initially treated with the afx2 abdominal aortic aneurysm stent; the case was considered off-label due to the patients neck anatomy.Approximately one (1) year post initial procedure, a type ia endoleak was detected.The physician plans to perform an open repair and will continue to monitor the patient.There have been no additional patient sequelae reported.
Additional Manufacturer Narrative
At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported event of type ia endoleak.This complaint is most likely user-related due to the off-label neck.Procedure-related harms included a type ii endoleak from the right renal accessory artery.The final patient condition could not be determined; the patient condition post planned open repair was not reported.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.
Event or Problem Description
Additional information received confirming that the physician is unresponsive regarding possible treatment for the reported endoleak.Clinical assessment confirmed a type ii endoleak was also present at the time of the reported event.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8160571
• Report Number: 2031527-2018-00937
• Device Sequence Number: 14004042
• Product Code: MIH
• UDI-Device Identifier: 00818009013552
• UDI-Public: (01)00818009013552(17)191024
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: 10/24/2019
• Device Model Number: A34-34/C100V
• Device Lot Number: 1605368-008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 03/09/2019
• 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: AFX2-AFX2 BIFURCATED STENT GRAFT:(B)(4); AFX2-AFX2 BIFURCATED STENT GRAFT:1517845-009
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR