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

Model Number A34-34/C80-O20 V

Device Problems Collapse (1099); Folded (2630)

Patient Problems Failure of Implant (1924); Occlusion (1984); Pain (1994); Claudication (2550)

Event Date 10/03/2017

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation.Devices have been discarded at the hospital.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.It was reported the patient came in emergently with pain and claudication.A computed tomography (ct) showed the suprarenal aortic extension had folded over itself and caused an occlusion in the aorta.Additionally it was reported during the implant procedure the physician lost wire access during the deployment of the suprarenal extension and may have deployed behind the strut of the bifurcated stent.The physician elected to explant the devices and complete an open repair.The patient is reported to be doing well post procedure.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were reported evidence that supported the following case event.Clinical was able to confirm that a user-error (unintentional) of the suprarenal stent deployment behind the main body stent had a lost wire access during the implant procedure (off-label technique and troubleshooting maneuver).Patient had never returned for a follow up after the initial implant, but eventually returned to a different hospital a year after that to treat for urgent presentation of pain/claudication.During that follow up, the ct showed the suprarenal aortic extension had folded in on itself and was causing an occlusion of the aorta.The physician explanted the devices on 10/03/2017 and were discarded at the hospital.The patient was reported to be doing well post explant.In addition clinical also found bilateral iliac occlusions; aortic stenosis from cuff to right common iliac artery; left endarterectomy; re-implantation of the inferior mesenteric artery; procedure-related left femoral artery endarterectomy and seroma; and bacteremia from a urinary tract infection.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 occlusion within the device (main body stent) and inadequate stent graft patency (cuff) was the unintentional user-error, which contributed to the main body stent collapse (buckling).The final patient disposition could not be determined due to the lack of relevant information surrounding the explant procedure; there has been no report of further negative patient sequelae.A review of the manufacturing lot confirmed all devices met specifications prior to release.The explanted devices will not be returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.

• 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: 6998478
• MDR Text Key: 90931180
• Report Number: 2031527-2017-00576
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009013606
• UDI-Public: (01)00818009013606(17)190623
• 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: 10/03/2017

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: Health Professional
• Device Expiration Date: 06/23/2019
• Device Model Number: A34-34/C80-O20 V
• Device Lot Number: 1491547-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 11/02/2017
• Supplement Dates Manufacturer Received: 10/03/2017
• Supplement Dates FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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
• Treatment: AFX2 BIFURCATED STENT GRAFT- 1516141-029
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR