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

Model Number	A28-28/C75V
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	09/11/2019
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 being implanted with a bifurcated stent graft (main body) and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).The main body was implanted as expected but during the implantation of the infrarenal proximal extension, the device was implanted in a false lumen of a dissection the was not visible in the pre-operation computed tomography (ct).The physician elected to implant a free-flow thoracic (non-endologix) device (terumo aortic) between the main body and the infrarenal proximal extension.This procedure is outside the indications of use (off- label).The proximal landing zone was the sma (superior mesenteric artery) because the patient was a dialysis patient.The thoracic device was then ballooned.The final angiogram revealed the restoration of the flow through the true lumen and a small unresolved intraoperative endoleak (indeterminate origin) in the aaa.The patient is being monitored and was reported as ok.
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, the reported intraoperative indeterminate endoleak and implantation of the proximal extension into a false lumen were unable to be confirmed due to the lack of relevant medical records and/or imaging available for review.Therefore device, user, procedure, anatomy relatedness or procedure related harms of these events could not be determined.The final patient status was reported to be under surveillance.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.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9168766
• Report Number: 2031527-2019-00449
• Device Sequence Number: 2830296
• Product Code: MIH
• UDI-Device Identifier: 00818009013514
• UDI-Public: (01)00818009013514(17)200721
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 07/21/2020
• Device Model Number: A28-28/C75V
• Device Lot Number: 1723274-003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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: AFX2 BIFURCATED STENT GRAFT, LOT 2037187-003
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR