MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; VELA INFRARENAL

Model Number	A28-28/C95V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354); Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924)
Date of Event	10/24/2017
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
Patient was initially implanted with a bifurcated, one infrarenal, one suprarenal and two limb extension on (b)(6) 2016.During a routine follow up, the physician noted an endoleak type ia through ultrasound.The physician elected to reline with a gore tag device.The leak was resolved and the patient was reported to be doing well post procedure.
Additional Manufacturer Narrative
At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; endoleak type ia.Additionally there was evidence to reasonably support the following observations; suprarenal cuff migration and sac growth.The most likely cause of the loss of seal and proximal cuff migration (30mm) was a combination of the off-label aortic neck angulation (intentional user error) and cautionary product use conditions of calcifications at the aortic neck and the use of non-contrast surveillance.The procedure related harms and final patient disposition could not be ascertained due to lack of medical information surrounding the secondary endovascular procedure.To date there have been no reports of further negative patient sequelae.Devices remain implanted in the patient and were not returned, no evaluation 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.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7035840
• Report Number: 2031527-2017-00614
• Device Sequence Number: 2036645
• Product Code: MIH
• UDI-Device Identifier: 00818009013521
• UDI-Public: (01)00818009013521(17)190210
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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: Physician
• Device Expiration Date: 03/16/2017
• Device Model Number: A28-28/C95V
• Device Lot Number: 1343252-008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/24/2018
• 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: 86 YR