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

Model Number	A34-34/C100-020V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Codes	Death (1802); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Renal Failure (2041); Pseudoaneurysm (2605)
Date of Event	06/30/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices remain implanted in the patient.
Event or Problem Description
It was reported the patient had an initial procedure on (b)(6) 2016 with a bifurcated, a suprarenal aortic extension, and two limb extensions.Subsequently, the physician noted on (b)(6) 2016 that the patient had either a persistent type 2 endoleak, or an endoleak type 1a, in the left common iliac and aorta.Physician elected to repair via open surgery on (b)(6) 2016.Surgery went well.The patient is in stable condition.
Additional Manufacturer Narrative
At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm a type 1b endoleak of the left common iliac artery, a type 2 endoleak, explant and surgical repair of the abdominal aortic aneurysm, and re-hospitalization and infection of the surgical graft.There is also evidence to support the following observations; patient was hospitalized with abdominal pain and sac growth prior to surgical conversion, after the surgical conversion the patient was readmitted to the hospital with abdominal pain and leukocytosis.Image studies demonstrated sac growth and pseudoaneurysm of the proximal aorta; a new fluid and gas collection surrounding the aorta; after antibiotics were started the next day during a surgical graph revision, the patient expired intraoperatively, massive blood loss, persistent, profound hypotension (shock) due to non-repairable aortic tissue, especially around the aortic neck area, and a type 3b endoleak of the proximal cuff and the presence of an infectious process and low attenuation in the proximal aortic neck during the suprarenal cuff implant.The clinical evaluation additionally found evidence to reasonably suggest the following contributing factors to the reported event; off label use, pre-existing condition with a calcified ulceration at the neck, dissection, and anticoagulation therapy.The review of the manufacturing lot confirmed all devices met specifications prior to release.The explanted devices were not returned for further evaluation.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event.
Event or Problem Description
Additional information received, the patient had an open repair and explant due to multiple persistent endoleaks, the types of leaks were unknown.A surgical graft was placed on (b)(6) 2016, it was reported on (b)(6) 2016 the surgical graft became infected and during removal the patient expired.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5835421
• Report Number: 2031527-2016-00378
• Device Sequence Number: 13571143
• Product Code: MIH
• UDI-Device Identifier: 00818009012265
• UDI-Public: (01)00818009012265
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2016

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: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: A34-34/C100-020V
• Device Lot Number: 1458318-020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2016
• Supplement Report FDA Received Date: 04/12/2017
• 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: Death; Required Intervention
• Patient Age: 62 YR