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

Model Number A28-28/C95-O20V

Device Problems Migration or Expulsion of Device (1395); Stretched (1601)

Patient Problem Failure of Implant (1924)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were substantial reported evidence that supported the following case event.In addition to the confirmed type 3a endoleak, component separation, and sac growth (reference 2031527-2018-00005), clinical was also able to confirm a cuff migration (20mm) and dilation of the stent graft and superior stent margin of the main body.A secondary procedure of a re-line was performed on (b)(6) 2018 to correct the issues.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the cuff migration was the off-label neck anatomy at the initial implant procedure.The most likely cause of the mid aortic loss of seal with complete component separation and loss of overlap of the main body and the cuff was the aortic remodeling caused by the migration.The most likely cause of the compromised stent graft integrity (stretched) of the main body (24%) and the cuff (36%) could not be determined, but it was likely the eventual loss of overlap contributed to this event.To date there has been no reports of further negative patient sequelae.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.

Event Description

On (b)(6) 2017, endologix was notified of a reported patient with a large type 3a endoleak with a noted aortic extension separation from the bifurcated main body device.Patient also was noted to have a aaa enlargement.Initial implant of the afx was done on (b)(6) 2015.On (b)(6) 2018, a successful re-line was done on patient with two (2) vela extensions placed to "bridge" the prior separated aortic extension.In addition, clincial noted on their final evaluation, that patient also had a cuff migration (20mm) and stent cage dilation (36%).

• Brand Name: AFX
• Type of Device: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7390495
• MDR Text Key: 104132290
• Report Number: 2031527-2018-00209
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013637
• UDI-Public: (01)00818009013637
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/23/2015
• Device Model Number: A28-28/C95-O20V
• Device Catalogue Number: F00786-09
• Device Lot Number: 1269249024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR