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

Model Number A34-34/C100-O20 V

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Leak/Splash (1354); Stretched (1601); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 10/18/2017

Event Type  Injury  

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 Description

During the initial procedure, the patient was implanted with an afx bifurcated and vela suprarenal and three limb extension was implanted for a hypogastric salvage that was performed with the placement of a gore viabahn.During the three year follow up, there was an endoleak type ia (reported in a seperated report) of suprarenal extension; it appeared to have been pulled out of the infrarenal neck.Afx left limb extension with the viabahn snorkeled slipped out of the main body and is an indication of an endoleak type iiia.Re-intervention is planned for (b)(6) 2017.No additional patient sequalae has been reported at this time.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; reline procedure to place a non-endologix stent in the aorta and left common iliac artery, coiled left hypogastric artery through snorkel, and endoleak type iiia in the left common iliac artery(reported in report #2031527-2017-00593).Clinical evaluations was unable to find substantial evidence to support the following reported events; endoleak type ia status post reline.Additionally there was evidence to reasonably support the following observations; sac growth, complete stent separation between the main body and left iliac limb, stent case dilation of the main body.The most likely cause of the loss of seal and the implant separation of the left iliac stents was the off-label iliac anatomy.Likewise, the most likely cause of the proximal loss of seal was the off-label aortic anatomy prior to and after the non endologix stent relining (intentional user error).Due to the lack of medical information surrounding the repair event, the procedure related harms and the final patient disposition could not be ascertained.However, post the repair procedure, reportedly, there was a persistent loss of seal proximally.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.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.(b)(4).

• 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
• MDR Report Key: 7015265
• MDR Text Key: 91746220
• Report Number: 2031527-2017-00592
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 0081009013651
• UDI-Public: (01)0081009013651(17)141108
• 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,Followup
• Report Date: 01/25/2018

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
• Device Operator: Physician
• Device Expiration Date: 11/08/2014
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1202749-016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2014
• 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: 66 YR