MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA SUPRARENAL

Model Number	A28-28/C75-O20V
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient; therefore, it will not be returned for evaluation.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 afx bifurcated stent graft and a vela suprarenal stent graft to treat an abdominal aortic aneurysm (aaa).Approximately six (6) years post initial implant, during routine follow up the computed tomography scan identified caudal migration of the proximal afx graft > 10mm.No further information provided.Patient status was not reported.Note: this patient is part of a clinical study.
Additional Manufacturer Narrative
After further review, the initial report to patient id (b)(6) was submitted with the wrong cfn/fei # (b)(4), which is not associated with the afx product line.Therefore, a corrective initial/final report will be submitted for patient id (b)(6) with the appropriate cfn/fei # (b)(4).Please see mfr.Report # 2031527-2021-00195.This event per mfr.Report # 3008011247-2021-00026 is thus no longer reportable.
Event or Problem Description
The patient was initially implanted with a afx bifurcated stent graft and a vela suprarenal stent graft to treat an abdominal aortic aneurysm (aaa).Approximately six (6) years post initial implant, during routine follow up the computed tomography scan identified caudal migration of the proximal afx graft > 10mm.No further information provided.Patient status was not reported.Note: this patient is part of a clinical study.Additional information: after further review, the initial report to patient id (b)(6) was submitted with the wrong cfn/fei # (b)(4), which is not associated with the afx product line.Therefore, a corrective initial/final report will be submitted for patient id (b)(6) with the appropriate cfn/fei # (b)(4).Please see mfr.Report # 2031527-2021-00195.This event per mfr.Report # 3008011247-2021-00026 is thus no longer reportable.

• Brand Name: AFX
• Common Device Name: VELA SUPRARENAL
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 11661290
• Report Number: 3008011247-2021-00026
• Device Sequence Number: 3127963
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)180922
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 09/22/2018
• Device Model Number: A28-28/C75-O20V
• Device Lot Number: 1252031023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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#1267165024.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR