MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C75-O20V
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/30/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On (b)(6) 2018, the patient was implanted with a bifurcated stent graft and a suprarenal stent graft extension.On (b)(6) 2018, endologix was made aware of both bifurcated stent graft and a suprarenal stent graft extension were occluded.The patient was presented to the hospital on (b)(6) 2018 with pain in both legs and abdomen.A computed tomography (ct) scan demonstrated occluded bifurcated graft and cuff.A reintervention was performed where both groins exposed, and thrombectomy catheters were passed through both iliacs, sfa's, and the abdominal aorta.The clot (occlusion) was removed.The main body and cuff were ballooned, followed by the placement of non- endologix stents in the common iliacs to successfully restoring flow through the stent graft and bilateral iliac arteries.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.This complaint is for the suprarenal stent graft extension only another report will be created/ submitted for the bifurcated stent graft.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The devices were not returned as the devices remains implanted therefore no evaluation was completed.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several attempts were made to obtain medical records and images but no response was received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7732073
• Report Number: 2031527-2018-00618
• Device Sequence Number: 19468409
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17200814
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2018

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: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 1728596-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2018
• Supplement Date Received by Manufacturer: 06/30/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIFURCATED STENT GRAFT, LOT # 1690693-008; BIFURCATED STENT GRAFT, LOT # 1690693-008
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR