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

Model Number	A28-28/C75-O20V
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Rupture (2208)
Date of Event	09/06/2019
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.Patient medical records and imaging studies will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with duraply.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately two (2) years post initial procedure, the patient was present in the emergency room (er) with abdominal and back pain.A computed tomography (ct) was performed and showed retroperitoneal hemorrhage.The patient was sent to another hospital for an intervention.Upon review of the computed tomography (ct) by the physician and radiologist, a type 1a endoleak was suspected as the proximal extension had moved 2 cm's from initial implantation.The physician elected to reline the original implanted devices with gore (non - endologix) stents to resolved this event and the patient was reported as doing well post intervention.
Event or Problem Description
The patient was initially implanted with a bifurcated stent graft and a suprarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately two (2) years post initial procedure, the patient was present in the emergency room (er) with abdominal and back pain.A computed tomography (ct) was performed and showed retroperitoneal hemorrhage.The patient was sent to another hospital for an intervention.Upon review of the computed tomography (ct) by the physician and radiologist, a type 1a endoleak was suspected as the proximal extension had moved 2 cm¿s from initial implantation.The physician elected to reline the original implanted devices with gore (non - endologix) stents to resolved this event and the patient was reported as doing well post intervention.Additional information: during the investigation of the reported event, clinical assessment confirmed a rupture based on medical records and imaging reviewed.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was unable to find substantial evidence to support the following event of the type ia endoleak and migration of the proximal extension of 20mm based on the medical records and imaging available to review.Clinical was able to find substantial evidence to support the rupture event.As such, procedure related harms, device, user, or anatomy relatedness of this event could not be determined with the medical records and imaging available to review.The patient was discharged on day six (6) following a secondary endovascular repair.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx with duraply.Corrections: h6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9136965
• Report Number: 2031527-2019-00445
• Device Sequence Number: 2547429
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)200619
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: 06/19/2020
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 1704062-006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 06/04/2020
• 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 1641441R001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR